Proactiveinvestors USA & Canada VolitionRx https://www.proactiveinvestors.com Proactiveinvestors USA & Canada VolitionRx RSS feed en Sun, 21 Jul 2019 20:30:04 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - VolitionRX brings its Nu.Q cancer-screening platform to China ]]> https://www.proactiveinvestors.com/companies/news/224160/volitionrx-brings-its-nuq-cancer-screening-platform-to-china-224160.html VolitionRx Limited (NYSEMKT:VNRX) is bringing its cancer-screening blood tests to China for a new lung cancer study.

The company is partnering with Shanghai Fosun Long March Medical Science Co Ltd, a manufacturer of diagnostic and laboratory instruments. The study will use Volition’s Nu.Q assays to screen for lung cancer at Fosun's hospitals, research institutions and clinics, among other locations.

The two parties previously signed a memorandum of understanding, and the study represents the execution of that contract.

READ: VolitionRx Limited awarded an additional $1.4 million in non-dilutive funding

Nu.Q functions as a routine blood test that looks for molecular signatures of cancer by focusing on the nucleosomes — a section of DNA wrapped around a core of proteins — in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes..

"The need for a simple, easy to use, cost effective test for cancer is truly universal and we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide," Volition CEO Cameron Reynolds said.

"We see Asia, and particularly lung cancer in China, as a key market for Volition. We are excited about the commencement of our work in China and look forward to a successful collaboration with Fosun Long March," he added.

According to Fosun chairman Yuejian Zhang, China accounts for 20% of the world's population but 24% of the world's lung cancer diagnoses and 30% of cancer-related deaths. 

Shares in Volition rose 4.2% to $3.50 Thursday morning.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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Thu, 18 Jul 2019 11:15:00 -0400 https://www.proactiveinvestors.com/companies/news/224160/volitionrx-brings-its-nuq-cancer-screening-platform-to-china-224160.html
<![CDATA[News - VolitionRx Limited awarded an additional $1.4 million in non-dilutive funding ]]> https://www.proactiveinvestors.com/companies/news/223687/volitionrx-limited-awarded-an-additional-14-million-in-non-dilutive-funding-223687.html VolitionRx Limited (NYSEAMERICAN:VNRX) revealed Wednesday that it has secured an additional $1.4 million in non-dilutive funding in the form of a non-repayable cash grant from the Walloon Region in southern Belgium.

To date, agencies from Walloon have awarded the Isnes, Belgium-based life-sciences company nearly $6 million in non-dilutive funding including the most recent award.

"It is a key part of our financing strategy to actively seek non-dilutive funding as this provides additional cash at favorable terms to support the company's continued development," said CEO Cameron Reynolds. "We are delighted with the great progress we are making on so many fronts and look forward to achieving many milestones throughout this year."

BIG PICTURE: VolitionRx’s Nu.Q cancer-screening blood tests could replace colonoscopies, biopsies

The company has designed routine Nu.Q blood-based diagnostic tests to screen for colorectal and prostate cancers that reduce the need for more invasive colonoscopies and biopsies. It might also work as a screening tool for endometriosis and has potential veterinary uses as well.

"We are delighted with the financial assistance that we have received from the Walloon Region and would like to thank Monsieur Pierre-Yves Jeholet, the Walloon Minister for Economy for his continued support,” said Dr Gaetan Michel, CEO of Volition's subsidiary, Belgian Volition SPRL. “This grant will support a specific project to be conducted in collaboration with GIGA at the University of Liege, Belgium."

GIGA is the University of Liège's interdisciplinary research institute in the biomedical sciences.

The project led by Dr Denis Mottet, head of the Protein Signaling and Interaction Laboratory at GIGA, will explore the mechanisms of Telomers (protein-DNA complexes) maintenance, inherent to cancer cells, as a tool for cancer diagnostics using Volition's Nucleosomics platform.

Volition’s NuQ platform looks for molecular signatures of cancer by focusing on the nucleosomes — a section of DNA wrapped around a core of proteins — in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes, which are analyzed by Nu.Q’s platform.

The company has already tested Nu.Q to detect prostate cancer. In August 2018 Volition announced preliminary data from an 84-patient study that showed its Nu.Q test kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Volition's R&D activities are currently centered in Belgium, with additional offices in Texas, London and Singapore.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 10 Jul 2019 09:32:00 -0400 https://www.proactiveinvestors.com/companies/news/223687/volitionrx-limited-awarded-an-additional-14-million-in-non-dilutive-funding-223687.html
<![CDATA[News - VolitionRx’s Nu.Q cancer-screening blood tests could replace colonoscopies, biopsies ]]> https://www.proactiveinvestors.com/companies/news/222612/volitionrxs-nuq-cancer-screening-blood-tests-could-replace-colonoscopies-biopsies-222612.html VolitionRx (NYSEAMERICAN:VNRX) is a multi-national life sciences company that develops easy-to-use blood-based cancer tests to accurately diagnose a range of cancers. It was founded in 2010 by Cameron Reynolds, who is its CEO.  

The diagnostic tests are based on the science of nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid to get an indication that a disease is present.

The NYSE-listed company has designed a routine blood test called Nu.Q to screen for colorectal and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. It might also work as a screening tool for endometriosis and has potential veterinary uses as well.

At Volition’s command and control center in Isnes, Belgium, more than 30 scientists are conducting the background work necessary to introduce Nu.Q blood tests to the public in Asia, Europe and the US.

At the center of it is Volition’s NuQ platform, which looks for molecular signatures of cancer by focusing on the nucleosomes – a section of DNA wrapped around a core of proteins – in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes, which are analyzed by Nu.Q’s platform.

The company has already tested Nu.Q to detect prostate cancer. In August 2018 Volition announced preliminary data from an 84-patient study that showed its Nu.Q test kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Inflection Points

Prostate cancer aside, Volition is executing a pact, through its wholly-owned subsidiary, Belgian Volition SPRL, to conduct its first large-scale lung cancer study with the National Taiwan University. The company expects to release preliminary data relating to the first 600 patient samples in the first quarter of 2020.

But the management team at Volition is also charging ahead in running trials for colorectal cancer at the same time.

In the US, Volition is taking part in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research Network.

Data is being collected from over 13,500 people in the US, a project that is set to be completed in 2020. 

The collection of a European study involving the evaluation of 4,500 people with 27 of the most prevalent cancers at the University of Bonn in Germany, has also finished.

And in 2018, Volition signed agreements with National Taiwan University to conduct two large-scale colorectal studies across Asia. The company expects to finish them in Asia in 2020 and in the US in early 2021.

The prospect of a routine blood test that can replace expensive and invasive procedures like colonoscopies and biopsies is drawing substantial investor interest, including from European government agencies as well as the Walloon Regional government, which oversees the French-speaking region of southern Belgium where the company’s Research & Development facility is based.

The company has also entered into a sales and distribution partnership with another life sciences group, Active Motif, that has paved the way for a sale of research-only kits based on its Nucleosomics technology.

Volition is aiming to partner with European governments to introduce triage tests, which would rely on Nu.Q tests to weed out people who are less likely to have colon cancer.

The first Nu.Q tests to detect colorectal cancer are likely to hit Europe by the end of next year, followed by Asia in 2020 and the US by 2021. Reynolds said the company won’t see “serious” revenue until 2021 or 2022.

But the company is also migrating far beyond its primary line of work in cancer detection. In its sights are the painful ovarian disease endometriosis, where it is collaborating with the University of Oxford to see whether Nu.Q blood-based tests can be used for diagnosis.

It’s also pushing into veterinary medicine and pursuing a tie-up with Texas A&M’s College of Veterinary Medicine & Biomedical Science after discovering that nucleosomes in the blood can also be detected in dogs.

Outlook

In May, Volition announced that it ended its first quarter with $16.2 million in cash and cash equivalents, up from $13.4 million at the end of 2018.

In addition, the company said it continues to manage its cash carefully with a cash burn of $3.9 million in the first quarter, which ended March 31.

"During the first quarter 2019, we further strengthened our balance sheet with existing investors exercising $6.7 million in aggregate amount of outstanding warrants to purchase shares of our common stock,” Reynolds said.

He added that “subsequent to the ending of the quarter, a further $5 million in warrants were exercised for cash, making a total of $11.7 million in warrants exercised this year."

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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Fri, 21 Jun 2019 13:32:00 -0400 https://www.proactiveinvestors.com/companies/news/222612/volitionrxs-nuq-cancer-screening-blood-tests-could-replace-colonoscopies-biopsies-222612.html
<![CDATA[Media files - VolitionRx well positioned as it enters Q2 after strengthening balance sheet ]]> https://www.proactiveinvestors.com/companies/stocktube/13277/volitionrx-well-positioned-as-it-enters-q2-after-strengthening-balance-sheet-13277.html Thu, 09 May 2019 13:17:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13277/volitionrx-well-positioned-as-it-enters-q2-after-strengthening-balance-sheet-13277.html <![CDATA[News - VolitionRx boosts cash reserves in 1Q ]]> https://www.proactiveinvestors.com/companies/news/219919/volitionrx-boosts-cash-reserves-in-1q-219919.html VolitionRx Limited (NYSE AMERICAN:VNRX) on Wednesday announced that it ended its first quarter with $16.2 million in cash and cash equivalents, growing its cash reserves. 

The life-sciences company noted that it had $13.4 million in cash and cash equivalents at the end of 2018. In addition, VolitionRx said it continues to manage cash carefully with a cash burn of $3.9 million in the first quarter, which ended March 31.

WATCH: VolitionRx well positioned as it enters Q2 after strengthening balance sheet

"During the first quarter 2019, we further strengthened our balance sheet with existing investors exercising $6.7 million in aggregate amount of outstanding warrants to purchase shares of our common stock,” said CEO Cameron Reynolds.

He added that “subsequent to the ending of the quarter, a further $5 million in warrants were exercised for cash, making a total of $11.7 million in warrants exercised this year."

The company has designed routine Nu.Q blood-based diagnostic tests to screen for colorectal and prostate cancers that reduce the need for more invasive colonoscopies and biopsies.

VolitionRx’s stock rose 2.15% Wednesday to close at $3.33 a share.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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Wed, 08 May 2019 16:33:00 -0400 https://www.proactiveinvestors.com/companies/news/219919/volitionrx-boosts-cash-reserves-in-1q-219919.html
<![CDATA[News - VolitionRx updates investors on Nu.Q technology progress, new paths to revenue at NYSE event ]]> https://www.proactiveinvestors.com/companies/news/218322/volitionrx-updates-investors-on-nuq-technology-progress-new-paths-to-revenue-at-nyse-event-218322.html VolitionRx Limited (NYSE AMERICAN:VNRX) updated shareholders and analysts Tuesday on promising early data on its Nu.Q technology platform,  plans for potential new paths to revenue, and progress on its lung cancer detection clinical trial program using its novel Nu.Q blood test.

Founder CEO Cameron Reynolds noted during the Capital Markets Day event at the New York Stock Exchange that it has been a “busy quarter” for the life sciences company, with the public announcement of a number of initiatives.

The company shared preliminary results from two proof of concept studies in lung cancer. Reynolds highlighted that Volition has signed a pact with the prestigious National Taiwan University through its wholly-owned subsidiary Belgian Volition SPRL to conduct a large-scale lung cancer study.

READ: VolitionRx expands its lung cancer detection clinical trial program using its novel Nu.Q blood test

The Isnes, Belgium-based company has designed routine Nu.Q blood-based diagnostic tests to screen for colorectal and prostate cancers that reduce the need for more invasive colonoscopies and biopsies. It could also work as a screening tool for endometriosis and has potential veterinary uses as well.

Volition’s unique Nu.Q technology looks for very early ‘nucleosomic’ markers of cancer. In other words, the Nu.Q technology uses an array of simple, cost-effective blood tests to identify early-stage cells before it spreads.

A comprehensive study will now be conducted by Professor Chen Jin-Shing in the department of surgery, at the National Taiwan University, where 1,200 subjects, including 1,000 with lung cancer, will undergo low-dose computed tomography (LDCT) scanning, which uses less radiation than a conventional CT scan.

"The early data of the Nu.Q technology platform is promising, but clearly larger scale studies are required,” said Professor Chen Jin-Shing who will be collaborating with Volition in evaluating its Nu.Q technology platform. “Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for a triage test which can improve the specificity of the low-dose CT scan currently used."

Volition expects to release preliminary data relating to the first 600 patient samples in first quarter of 2020.

Positive preliminary results

Volition recently shared preliminary results from two proof-of-concept studies. In a recent lung cancer cohort, involving 76 subjects, a single Nu.Q assay test detected lung cancer, including stage 1 lung cancer.

A second lung cancer study, evaluating 152 subjects, also detected lung cancer and a third study using a single Nu.Q assay to determine the presence of colorectal cancer in 123 subjects also picked up the presence of colorectal cancer with an Area Under the Curve (AUC) of 72%.

Push into veterinary market

VolitionRx is also seeing encouraging preliminary results from the use of its Nu.Q. platform in veterinary medicine after discovering that nucleosomes in the blood can also be detected in dogs. The company is working with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet, a key target market for early revenue given the simpler regulatory pathway for veterinary products.

On Tuesday, Belgian Volition SPRL inked a collaborative research pact with Texas A&M University to focus on the veterinary diagnostic market utilizing its easy to use, cost-effective blood tests to help diagnose a range of cancers.

READ: VolitionRx subsidiary inks pact with Texas A&M University to develop Nu.Q veterinary diagnostic blood tests

The Memorandum of Understanding explores the idea of Belgian Volition forming a new subsidiary in the US to focus on the veterinary diagnostic market utilizing its nucleosomics technology with Texas A&M University collaborating further on R&D and potentially taking a stake in the new entity.

The US is currently the largest veterinary market in the world, with more than 55 million dogs and approximately 4.2 million cancer diagnoses each year.

Dr Jason Terrell, CEO of Volition America Inc said that there are currently no accurate, simple, affordable cancer screening or diagnostic tests available in veterinary medicine.

“And yet 25% of dogs will develop cancer at some stage of their life,” said Dr Terrell. “With pricing currently expected to be between $100-$200 per test, we believe that this is a multi-billion-dollar opportunity. We aim to have the first Nu.Q Vet product on the market in the US in 2020."

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 10 Apr 2019 07:57:00 -0400 https://www.proactiveinvestors.com/companies/news/218322/volitionrx-updates-investors-on-nuq-technology-progress-new-paths-to-revenue-at-nyse-event-218322.html
<![CDATA[Media files - VolitionRX hosts Capital Markets Day at the NYSE ]]> https://www.proactiveinvestors.com/companies/stocktube/12934/volitionrx-hosts-capital-markets-day-at-the-nyse-12934.html Tue, 09 Apr 2019 12:14:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12934/volitionrx-hosts-capital-markets-day-at-the-nyse-12934.html <![CDATA[News - VolitionRx subsidiary inks pact with Texas A&M University to develop Nu.Q veterinary diagnostic blood tests ]]> https://www.proactiveinvestors.com/companies/news/218248/volitionrx-subsidiary-inks-pact-with-texas-am-university-to-develop-nuq-veterinary-diagnostic-blood-tests-218248.html VolitionRx Ltd’s (NYSE AMERICAN:VNRX) wholly owned subsidiary Belgian Volition SPRL inked a collaborative research pact Tuesday with Texas A&M University to focus on the veterinary diagnostic market utilizing its easy to use, cost-effective blood tests to help diagnose a range of cancers.

The Isnes, Belgium-based company has currently designed routine Nu.Q blood-based diagnostic tests to screen for colorectal and prostate cancers in humans that reduce the need for more invasive colonoscopies and biopsies.

VolitionRx is also seeing encouraging preliminary results from the use of its Nu.Q. platform in veterinary medicine after discovering that nucleosomes in the blood can also be detected in dogs. The blood tests are based on the science of nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream — an indication that cancer is present.

Volition shares added a penny to $3.11 in late-morning trade.

READ: VolitionRx moves into veterinary medicine after encouraging study results

The company is working with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet, a key target market for early revenue given the simpler regulatory pathway for veterinary products.

This Memorandum of Understanding explores the idea of Belgian Volition forming a new subsidiary in the US to focus on the veterinary diagnostic market utilizing its nucleosomics technology with Texas A&M University collaborating further on R&D and potentially taking a stake in the new entity.

"The Texas A&M University College of Veterinary Medicine Oncology Department is excited for the opportunity to collaborate with Volition after some encouraging early work we have done together,” said Dr Heather Wilson-Robles, an associate professor at the Texas A&M College of Veterinary Medicine. “Volition's innovative work in the early identification of cancer has the potential to significantly impact veterinary oncology as we know it."

Tapping the US veterinary market 

The US is currently the largest veterinary market in the world with more than 55 million dogs and approximately 4.2 million cancer diagnoses each year.

"Volition's extensive intellectual property portfolio includes coverage of veterinary applications and we believe that not only could Nu.Q Vet potentially provide significant revenue for Volition, it may also provide further technical validation of our platform in human diagnostics," said Volition CEO Cameron Reynolds. "We are delighted to sign this MOU with Texas A&M and look forward to further developing our relationship together."

Dr Jason Terrell, CEO of Volition America Inc noted that there are currently no accurate, simple, affordable cancer screening or diagnostic tests available in veterinary medicine.

“And yet 25% of dogs will develop cancer at some stage of their life,” said Dr Terrell. “With pricing currently expected to be between $100-$200 per test, we believe that this is a multi-billion-dollar opportunity. We aim to have the first Nu.Q Vet product on the market in the U.S. in 2020." 

— Updates with share price —

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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Tue, 09 Apr 2019 11:31:00 -0400 https://www.proactiveinvestors.com/companies/news/218248/volitionrx-subsidiary-inks-pact-with-texas-am-university-to-develop-nuq-veterinary-diagnostic-blood-tests-218248.html
<![CDATA[News - VolitionRx expands its lung cancer detection clinical trial program using its novel Nu.Q blood test ]]> https://www.proactiveinvestors.com/companies/news/217886/volitionrx-expands-its-lung-cancer-detection-clinical-trial-program-using-its-novel-nuq-blood-test-217886.html VolitionRx Limited (NYSEAmerican:VNRX) said Wednesday that the cancer-focused life sciences company is executing a pact, through its wholly-owned subsidiary, Belgian Volition SPRL, to conduct its first large-scale lung cancer study with the National Taiwan University.

To that end, Belgian Volition SPRL inked a non-binding Memorandum of Understanding with the prestigious national university in Taipei City, Taiwan.

The Isnes, Belgium-based company has designed routine Nu.Q blood-based diagnostic tests to screen for colorectal and prostate cancers that reduce the need for more invasive colonoscopies and biopsies. It could also work as a screening tool for endometriosis and has potential veterinary uses as well.

READ: VolitionRx strengthens balance sheet in 2018 as Nu.Q blood test notches further advances in cancer-detection trials

VolitionRx Limited’s unique Nu.Q technology looks for very early ‘nucleosomic’ markers of cancer. In other words, the Nu.Q technology uses an array of simple, cost-effective blood tests to identify early-stage cells before it spreads.

A comprehensive study will now be conducted by Professor Chen Jin-Shing in the department of surgery, at the National Taiwan University, where 1,200 subjects, including 1,000 with lung cancer, will undergo low-dose computed tomography (LDCT) scanning, which uses less radiation than a conventional CT scan.

"The early data of the Nu.Q technology platform is promising, but clearly larger scale studies are required,” said Professor Chen Jin-Shing who will be collaborating with Volition in evaluating its Nu.Q technology platform. “Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for a triage test which can improve the specificity of the low-dose CT scan currently used."

"At a total cost of approximately $320,000 payable over two years, this study demonstrates once more Volition's commitment to conducting large yet cost effective trials worldwide,” said Dr Jasmine Kway, CEO of Singapore Volition. “We are hopeful that our recent proof of concept results in lung cancer will be repeated in this much larger cohort. We expect to release preliminary data relating to the first 600 patient samples to be reported in first quarter of 2020."

Positive preliminary results

Volition recently shared preliminary results from two proof-of-concept studies. In a recent lung cancer cohort, involving 76 subjects, a single Nu.Q assay test detected lung cancer, including stage 1 lung cancer.

A second lung cancer study, evaluating 152 subjects, also detected lung cancer and a third study using a single Nu.Q assay to determine the presence of colorectal cancer in 123 subjects also picked up the presence of colorectal cancer with an Area Under the Curve (AUC) of 72%.

VolitionRx is also seeing encouraging preliminary results from the use of its Nu.Q. platform in veterinary medicine after discovering that nucleosomes in the blood can also be detected in dogs. The company is working with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet, a key target market for early revenue given the simpler regulatory pathway for veterinary products.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Wed, 03 Apr 2019 10:09:00 -0400 https://www.proactiveinvestors.com/companies/news/217886/volitionrx-expands-its-lung-cancer-detection-clinical-trial-program-using-its-novel-nuq-blood-test-217886.html
<![CDATA[Media files - VolitionRx well funded as it advances development of its novel cancer tests ]]> https://www.proactiveinvestors.com/companies/stocktube/12599/volitionrx-well-funded-as-it-advances-development-of-its-novel-cancer-tests-12599.html Thu, 14 Mar 2019 15:02:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12599/volitionrx-well-funded-as-it-advances-development-of-its-novel-cancer-tests-12599.html <![CDATA[News - VolitionRx strengthens balance sheet in 2018 as Nu.Q blood test notches further advances in cancer-detection trials ]]> https://www.proactiveinvestors.com/companies/news/216482/volitionrx-strengthens-balance-sheet-in-2018-as-nuq-blood-test-notches-further-advances-in-cancer-detection-trials-216482.html VolitionRx Limited (NYSEAmerican:VNRX) strengthened its balance sheet and grew its patents in 2018 as the cancer-focused life sciences company continued to advance the development of its novel blood tests to cover testing for several cancers as well as other diseases.

CEO Cameron Reynolds says further development of Volition’s Nu.Q Capture and Nu.Q Vet products as well as the strengthening of Volition’s product pipeline beyond colorectal cancer to include several cancers and other diseases will help “drive early revenue.”

The Isnes, Belgium-based company has designed a routine blood test to screen for colorectal and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. It could also work as a screening tool for endometriosis and has potential veterinary uses as well.

READ: VolitionRx's revolutionary Nu.Q blood tests could change the future of cancer screening

Last year, the company bolstered its balance sheet thanks to existing investors exercising $6.7 million in outstanding warrants to purchase shares of stock. As of the end of December, its cash position came to $13.4 million, up from $10.1 million at the close of 2017.

It also managed cash carefully with a steady average quarterly burn (or cash used in operating activities) of about $3.9 million during 2018.

On the patent front, VolitionRx has been granted seven US patents, seven patents in the EU, and another 25 patents worldwide. On top of this, a further 106 patents are pending around the world.

The company has also had considerable success with clinical trials as underlined by the preliminary results from its first product grade assays.

“During 2018, we, together with our collaborators, have made significant progress, particularly with the work on the basics of our Nu.QTM platform and its expansion into exciting new areas,” added Reynolds in a statement.

READ: VolitionRx's Nu.Q blood-based diagnostic tests offer great potential, says Oppenheimer analyst

In a recent lung cancer cohort, involving 76 subjects, a single Nu.Q assay test detected lung cancer, including stage 1 lung cancer. A second lung cancer study, evaluating 152 subjects, also detected lung cancer and third study using a single Nu.Q assay to determine the presence of colorectal cancer in 123 subjects also picked up the presence of colorectal cancer with an Area Under the Curve (AUC) of 72%.

“The above proof of concept results give us confidence to move onto potentially dozens of other assays that we have under development, and the large range of cohorts and trials we have collected and planned,” VolitionRx said in a statement.

In other advances, VolitionRx is also seeing encouraging preliminary results from the use of its Nu.Q. platform in veterinary medicine after discovering that nucleosomes in the blood can also be detected in dogs. The company is working with Texas A&M University’s College of Veterinary Medicine to conduct a study of Nu.Q Vet, a key target market for early revenue given the simpler regulatory pathway for veterinary products.

It’s also developing Nu.Q. Capture, which investigates the use of Nucleosomics to purify or enrich tumor-associated nucleosomes. The first studies have shown that Nu.Q Capture is able to deplete or enrich nucleosomes by 70 to 90% using magnetic beads in serum and plasma. “This is still a work in progress, but it is a great first step and one our scientific team is extremely excited by,” Volition said in its release.

Volition’s operations are still in the research and development stage and the company reported no revenue last year.

Outlook in focus

Looking ahead to 2019, VolitionRx is set to advance its large-scale colorectal cancer trials in Europe, the US and Asia.

It’s also planning a route to revenue for Nu.Q Vet with the aim of having a US Department of Agriculture-approved product in 2020.

Also on the agenda is a clinical trial program for lung cancer that focuses initially on the significant need for testing in Asia and China in particular.

Preliminary results evaluating Nu.Q’s performance in detecting other diseases, including endometriosis, are also expected, and so are the results of multiple proof of concept cancer studies that include prostate, pancreatic, ovarian and head and neck in addition to the company’s 27-cancer study.

VolitionRx is hosting a Capital Markets day at the New York Stock Exchange on April 9, which will include presentations from both Professor Axel Imhof of the Biomedical Center of the Ludwig-Maximilians University of Munich and Heather Wilson-Robles, an associate professor at Texas A&M's Veterinary School.

VolitionRx shares closed at $3.45 on Wednesday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Thu, 14 Mar 2019 08:39:00 -0400 https://www.proactiveinvestors.com/companies/news/216482/volitionrx-strengthens-balance-sheet-in-2018-as-nuq-blood-test-notches-further-advances-in-cancer-detection-trials-216482.html
<![CDATA[Media files - Growth 'guaranteed' for a well funded Volition Rx ]]> https://www.proactiveinvestors.com/companies/stocktube/11135/growth-guaranteed-for-a-well-funded-volition-rx-11135.html Thu, 08 Nov 2018 09:01:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11135/growth-guaranteed-for-a-well-funded-volition-rx-11135.html <![CDATA[News - VolitionRx reports several highlights in 2018 and eyes key milestones going into 2019 ]]> https://www.proactiveinvestors.com/companies/news/208777/volitionrx-reports-several-highlights-in-2018-and-eyes-key-milestones-going-into-2019-208777.html VolitionRx Limited (NYSEMKT:VNRX) said Wednesday it has achieved several highlights and is looking forward to a number of milestones going into 2019 for all its potential product lines.

"We have had numerous highlights this quarter, with good progress being made on many fronts demonstrating the diverse nature of our platform technology." said VolitionRx's president and CEO, Cameron Reynolds.

For the remainder of 2018 into 2019, VolitionRx is targeting several important clinical and commercial milestones.

They include receiving data on both the Triage and the frontline colorectal cancer screening products, securing an additional mid-size US colorectal cancer study to support the US regulatory strategy. Volition is also strengthening their intellectual property rights by obtaining additional key patents in several countries, including in the US.

The Belgium-based company is also securing large prostate trials and announcing a development pathway to commercialization of products for such indications. It is also developing a veterinary product strategy in conjunction with receiving data from trials involving the three most prevalent dog cancers.

BIG PICTURE: VolitionRx's revolutionary Nu.Q blood tests could change the future of cancer screening

Volition is increasing revenue from the sales of Research Use Only kits. Volition is receiving preliminary "proof of concept" data on the validity of its Nu.Q technology platform from trials including the Bonn27 study and the endometriosis study.

"The first Research Use Only kit was launched in August and we expect to add to the range of kits by the end of 2018," Reynolds said.

He said the research and development team in Belgium is "hard at work on the significant task of turning our assays into robust products that can be used worldwide. This development work will be key to our future success and is now very much bearing fruit." The company welcomed Professor Han-Mo Chiu of National Taiwan University, the principal investigator of the Pan-Asian colorectal cancer studies, to its Belgium facility.

Among the highlights in the third quarter, Volition released encouraging preliminary data from a prospective, multi-centered proof of concept study into the utility of Volition's Nu.Q assays to diagnose men with high-grade prostate cancers. At 88% specificity, the Volition assays identified 94% of high-grade prostate cancers that require treatment.

MAJOR CANCER STUDIES UNDERWAY IN ASIA-PACIFIC

The company signed agreements to conduct two large-scale colorectal cancer research studies across the Asia-Pacific region in collaboration with the National Taiwan University. The first study will comprise 5,000 asymptomatic colorectal cancer screening subjects, and the second trial will include up to 2,000 symptomatic colorectal cancer patients.

The studies are being conducted to test and validate Volition's proprietary Nu.Q platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes. The studies will cost approximately $2.55 million payable over three years and should assist product development in Asia in 2019.

Volition has also launched and achieved sales of the Nu.Q Total assay kit, the first of our range of Research Use Only kits through its exclusive global distributor, Active Motif.

"We expect to add further products for Research Use Only during the balance of 2018, building through next year and beyond," the company said in a statement.

Volition began work on the Bonn27 study, which is a 4,500-patient cohort that has been collected by the University of Bonn, Germany, and includes patients with 27 of the most prevalent cancers.

The company started proof of concept work in one of its non-cancer disease areas. This study is in collaboration with the University of Oxford, which has completed a collection of 350 patient samples over the last three years.

READ: VolitionRx moves into veterinary medicine after encouraging study results

Volition expanded its Nu.QTM trials into veterinary diagnostics following encouraging preliminary results from initial proof of concept studies in dogs and more recently horses. Volition announced a pilot study in collaboration with Texas A&M College of Veterinary Medicine & Biomedical Sciences as a first step toward developing a product commercialization strategy.

Reynolds said they have strengthened the company's balance sheet "with completion of a private placement (PIPE) of shares of common stock and a warrant with an existing accredited investor resulting in gross proceeds of $9 million, securing an additional $700,000 in non-dilutive funding from the Walloon Regional Government; and most recently, the exercise of outstanding warrants that provided approximately $717,000 in additional funds to the company."

VolitionRx is a life sciences company focused on developing simple, easy to use, cost-effective blood tests designed to help diagnose a range of cancers.

For the three months ended September 30, 2018, Volition reported a net loss of $4.48 million, or $0.14 per share. This compares to a net loss of $3.89 million, or $0.15 per share, in the third quarter of 2017.


Reporting by Rene Pastor, contactable on rene.pastor@proactiveinvestors.com

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Wed, 07 Nov 2018 16:53:00 -0500 https://www.proactiveinvestors.com/companies/news/208777/volitionrx-reports-several-highlights-in-2018-and-eyes-key-milestones-going-into-2019-208777.html
<![CDATA[News - VolitionRx's revolutionary Nu.Q blood tests could change the future of cancer screening ]]> https://www.proactiveinvestors.com/companies/news/207876/volitionrx-s-revolutionary-nuq-blood-tests-could-change-the-future-of-cancer-screening-207876.html While VolitionRx’s Nu.Q diagnostic blood tests are deceptively simple, their impact promises to be momentous.

The NYSE-listed company has designed a routine blood test to screen for colorectal and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. It might also work as a screening tool for endometriosis and has potential veterinary uses as well.

“We can do a lot of good with what we’re doing,” says VolitionRx CEO Cameron Reynolds. “Now that we’ve done the background work we need to do with our blood assays, we’re very close to launching the different products for different cancers and diseases. I think people realize we have something very special. No one has really worked in nucleosomes in the way we have before.”

To consider VolitionRx as an investment play, one must look at the dazzling science behind its technology. At its command and control center in Isnes, Belgium, more than 30 scientists are conducting the background work necessary to introduce VolitionRx’s key Nu.Q blood tests to the public.

At the center of it is VolitionRx’s NuQ platform, which looks for molecular signatures of cancer by focusing on the nucleosomes – a section of DNA wrapped around a core of proteins – in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of the malignant disease appear on the nucleosomes, which are analyzed by Nu.Q’s platform.

The first Nu.Q tests to detect colorectal cancer are likely to hit Europe by the end of next year, followed by Asia in 2020 and the US by 2021. But Reynolds says the company won’t see “serious” revenue until 2021 or 2022.

Volition tackles trials around the world

Currently, Volition is focused on research and development and the company is deep in clinical trials around the globe.

In one of its biggest successes to date, Volition announced in August preliminary data from an 84-patient study that showed its Nu.Q blood assay kits diagnosed men with aggressive prostate cancer with 94% accuracy. This was a remarkable result, as a number of current diagnostic exams are not able to distinguish with subtlety the severity of prostate cancer, Reynolds says.

“The trial was to prove could we show the aggressive forms of prostate cancer from the non-aggressive ones and the results were excellent,” Reynolds says.

“The trial was statistically significant, but it was under 100 patients,” he adds. “So, now we’re in the process of trying to organize very large trials in prostate cancer because that’s a product that would be tremendously useful clinically.”

As its work in prostate cancer gathers pace, the management team at VolitionRx is also charging ahead in running trials for colorectal cancer at the same time.

In the US, Volition is taking part in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research Network.

Data is being collected from over 13,500 people in the US, a project that is set to be completed in 2020.  

The collection of a European study involving the evaluation of 4,500 people with 27 of the most prevalent cancers at the University of Bonn in Germany, has also finished. And earlier this year, Volition signed agreements with National Taiwan University to conduct two large-scale colorectal studies across Asia.

“We’re getting to the stage where we’re almost ready to finish those large product trials – for triage and for front-line colorectal tests in Europe,” reports Reynolds. “And we expect to finish them in Asia in 2020 and in the US in early 2021.”

Other diseases and veterinary work beckon

But the company is also migrating far beyond its primary line of work in cancer detection. In its sights are the painful ovarian disease endometriosis, where it is collaborating with the University of Oxford to see whether Nu.Q blood-based tests can be used for diagnosis. While Reynolds is unsure whether the same technology can be used on endometriosis, it’s worth a shot.  

It’s also pushing into veterinary medicine and pursuing a tie-up with Texas A&M’s College of Veterinary Medicine & Biomedical Science after discovering that nucleosomes in the blood can also be detected in dogs. “We’re seeing very promising results in veterinary uses,” reports Reynolds.

”Dogs are obviously different to humans in what’s important. We’re relying on consultants and experts including Texas A&M to really help us with that.”

The promise of the science draws investors

The prospect of a routine blood test that can replace expensive and invasive procedures like colonoscopies and biopsies is drawing substantial investor interest, including from European government agencies as well as the Walloon Regional government, which oversees the French-speaking region of southern Belgium where the company’s Research & Development facility is based.

As is the case with companies at this formative stage of their development, Volition saw losses of $4.6 million in the second quarter.

But over the summer, a shareholder committed to invest $9 million, adding to the $11.9 million the company already had in cash on hand at the close of June. “That makes over $20 million, which gives us a lot of runway,” Reynolds says.

The company has also entered into a sales and distribution partnership with another life sciences group, Active Motif, that has paved the way for a sale of research-only kits based on its Nucleosomics technology.

The kits cost $500 to $1,000, but if the buyer discovers something interesting in the blood assays, they must return to Volition for product licenses, another potential revenue generator. “The basic idea is to get the kits out there and to get them to as many groups, organizations and universities as possible and to really make sure our technology is being used as widely as possible.”

READ: VolitionRx's Nu.Q blood-based diagnostic tests offer great potential, says Oppenheimer analyst

Reynolds, an Australian with a commerce degree and an MBA from the University of Western Australia, set up Volition in 2010 while living in Singapore. Indeed, the company owes much of its achievements to the now-defunct UK biotech Chroma Therapeutics, whose scientists first demonstrated that cancer could be detected in a blood test by measuring nucleosomes containing chemically-modified histone proteins. While in Asia, the company’s technology drew the attention of Reynolds, who applied his business acumen, recruited its staff and eventually went on to acquire its patents.

Since starting off as a fledgling idea, Volition, which floated on the NYSE in 2015, has evolved into a business with considerable international reach that may well one day radically transform the way doctors screen for various cancers.

Its team includes Dr Alan Colman who was formerly the research director at PPL Therapeutics, the Scottish company involved in funding the cloning of Dolly the Sheep and chief scientific officer Jake Micallef who previously worked for Chroma as well as the World Health Organization and the NHS in the UK. Dr Jorge Reis-Filho, the director of experimental pathology at the Memorial Sloan Kettering Cancer center in New York also sits on its scientific advisory board.

Partnerships with governments ahead

Reynolds is confident that VolitionRx’s scientific achievements will translate soon into a sound commercial proposition. As early as next year, the company is aiming to partner with European governments to introduce triage tests, which would rely on Nu.Q tests to weed out people who are less likely to have colon cancer.

The company also wants to target the tens of millions of people who decline colonoscopies. “It’s hard to beat a technician with a camera and until we are as accurate as a colonoscopy, we absolutely will go for the non-compliant market,” says Reynolds. “It’s a huge market. … almost 30 million Americans are not up-to-date with their screening – a simple blood test could change that.”

It is the science being conducted at Volition’s 20,000 square foot facility in Isnes that has put the company on the path to success, with governments and the private sector in colorectal, prostate and veterinary screenings, each potentially multi-billion-dollar markets. And while Reynolds might be a businessman by training, this job has made him an idealist.

“The work has to be done and it has to be done right,” he concludes. “It’s taken time to do things properly and robustly, but it’s all coming to fruition now. We want to save lives.”

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Thu, 25 Oct 2018 13:01:00 -0400 https://www.proactiveinvestors.com/companies/news/207876/volitionrx-s-revolutionary-nuq-blood-tests-could-change-the-future-of-cancer-screening-207876.html
<![CDATA[News - VolitionRx moves into veterinary medicine after encouraging study results ]]> https://www.proactiveinvestors.com/companies/news/206405/volitionrx-moves-into-veterinary-medicine-after-encouraging-study-results-206405.html VolitionRx Ltd (NYSE AMERICAN:VNRX) announced Thursday that it is pushing into the area of veterinary medicine after seeing “very encouraging” preliminary results from a proof of concept study using its key NuQ diagnostic blood tests for cancer testing in dogs.

The study showed that nucleosomes in the blood – which are evaluated for the presence of cancer by the company’s NuQ diagnostic blood tests – can also be detected in dogs. This means that the same cancer diagnosis method applied to humans is likely to work on animals and Volition will now test its NuQ platform in larger trials for veterinary medicine.

Volition’s NuQ diagnostic blood tests, which are now used to screen for colorectal and prostate cancers, work effectively as cancer leads to irregular levels of nucleosomes -a section of DNA wrapped around a core of proteins – in the blood. By measuring and analyzing the nucleosomes, the NuQ tests identify cancers.

The stock added 2.4% to $2.95 in Thursday’s morning trading session on the news.

Read: VolitionRx's Nu.Q blood-based diagnostic tests offer great potential, says Oppenheimer analyst

Volition’s intellectual property portfolio includes coverage of veterinary medicine applications. But the Belgium-based company intends to outsource much of the clinical trial work required in the veterinary area to partners and keep its focus on clinical research for human cancers.

The company plans to determine the performance of Nu.Q  assays for larger trials in the most prevalent forms of canine malignancies in partnership with Dr. Heather Wilson-Robles an associate professor with Texas A&M College of Veterinary Medicine & Biomedical Sciences in the Small Animal Clinical Sciences department.

“We're confident this partnership will provide the framework to expedite the development and commercialization of our veterinary diagnostic platform,” said Dr. Jason Terrell, CEO of Volition America, in a statement.

Read: VolitionRx expects its Nu.Q blood-based test kits to generate new revenue in coming quarter

“The U.S. is currently the largest veterinary market in the world and has a clearly defined regulatory pathway via the USDA, requiring fewer and smaller clinical studies than the FDA process for human diagnostics. This generally allows a much faster route to revenue for veterinary products as compared to human products," Terrell added.

Volition’s new push into veterinary medicine was announced at the 10th anniversary meeting of the Belgian Technology Mission at Texas A&M University. The meeting was sponsored in part by the Wallonia Export-Investment Agency, a long-standing supporter of Volition in Belgium.

Volition is a life sciences company focused on developing simple, easy-to-use and cost-effective blood tests designed to diagnose a range of cancers. While its research and development activities are based in Belgium, the company has offices in London, Texas and Singapore.

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Thu, 04 Oct 2018 09:40:00 -0400 https://www.proactiveinvestors.com/companies/news/206405/volitionrx-moves-into-veterinary-medicine-after-encouraging-study-results-206405.html
<![CDATA[Media files - VolitionRx releases prostate cancer data, moving towards larger trials ]]> https://www.proactiveinvestors.com/companies/stocktube/10718/volitionrx-releases-prostate-cancer-data-moving-towards-larger-trials-10718.html Wed, 03 Oct 2018 08:50:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/10718/volitionrx-releases-prostate-cancer-data-moving-towards-larger-trials-10718.html <![CDATA[News - VolitionRx's Nu.Q blood-based diagnostic tests offer great potential, says Oppenheimer analyst ]]> https://www.proactiveinvestors.com/companies/news/202970/volitionrx-s-nuq-blood-based-diagnostic-tests-offer-great-potential-says-oppenheimer-analyst-202970.html The easy-to-use Nu.Q blood-based diagnostics tests offered by VolitionRx Ltd (NYSEAMERICAN:VNRX) will provide a key tool in screening for colorectal cancer going forward, says Mark Breidenbach, an analyst with Oppenheimer.

In a note to investors, Breidenbach argues that the Belgium-based company’s diagnostic tests for different cancers can “meaningfully improve the gap in screening compliance for colorectal cancer.”

“We see the company’s products for colorectal cancer screening as its primary value drivers,” he added.

Breidenbach’s valuation of VolitionRx is based primarily on Nu.Q’s market opportunity for colorectal cancer screening in the US and European Union.

Currently, VolitionRx develops and markets its cost-effective Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx’s Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

On Monday, VolitionRx revealed that it expects modest initial revenue starting in the coming quarter due to the sale of its Nu.Q blood-based tests.

Read: VolitionRx expects its Nu.Q blood-based test kits to generate new revenue in coming quarter

Among the Belgium-based company’s recent wins announced along with second-quarter results is a sales agreement with Active Motif for an array of Research-Use-Only kits, the first of which, the Nu.Q Total assay kit is now on the market.

“We expect modest initial revenue in the coming quarter, building through next year and beyond,” the company said in a statement.

Additional advances announced at the end of the second quarter include VolitionRx’s move to sign agreements to conduct two colorectal cancer research studies across Asia in collaboration with the National Taiwan University.

The company also released preliminary data from a study that showed its Nu.Q assay kits diagnosed men with aggressive prostate cancer with 94% accuracy, which prompted praise from Breidenbach.

Read: VolitionRx unveils data showing its Nu.Q assays detect aggressive prostate cancer in men with 94% accuracy

“While we caution against making broad conclusions from small pilot studies, we believe these data highlight the potential of VolitionRx’s tech platform in applications well beyond colorectal cancer,” Breidenbach wrote.

VolitionRx ended the second quarter with US$11.9mln in cash, which combined with its recent US$9mln private placement, could sustain its business operations until the middle of next year, Breidenbach added.

The analyst reiterated his Outperform rating on VolitionRx, but adjusted his price target to US$6 from US$7 to reflect delays in clinical trials involving the Nu.Q tests.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

 

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Wed, 15 Aug 2018 09:14:00 -0400 https://www.proactiveinvestors.com/companies/news/202970/volitionrx-s-nuq-blood-based-diagnostic-tests-offer-great-potential-says-oppenheimer-analyst-202970.html
<![CDATA[Media files - VolitionRx 'has a lot of shots on goal' as development of assays advances ]]> https://www.proactiveinvestors.com/companies/stocktube/10114/volitionrx-has-a-lot-of-shots-on-goal-as-development-of-assays-advances-10114.html Tue, 14 Aug 2018 14:00:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/10114/volitionrx-has-a-lot-of-shots-on-goal-as-development-of-assays-advances-10114.html <![CDATA[News - VolitionRx expects its Nu.Q blood-based test kits to generate new revenue in coming quarter ]]> https://www.proactiveinvestors.com/companies/news/202793/volitionrx-expects-its-nuq-blood-based-test-kits-to-generate-new-revenue-in-coming-quarter-202793.html VolitionRx Ltd (NYSEAMERICAN:VNRX), which is focused on developing blood-based diagnostics tests for different cancers, on Monday revealed that it expects modest initial revenue starting in the coming quarter due to the sale of its easy-to-use Nu.Q blood-based tests.

Among the Belgium-based company’s recent wins announced along with second-quarter results is a sales agreement with Active Motif for an array of Research-Use-Only kits, the first of which, the Nu.Q Total assay kit is now on the market.

“We expect modest initial revenue in the coming quarter, building through next year and beyond,” the company said in a statement.

Additional advances announced at the end of the second quarter include VolitionRx’s move to sign agreements to conduct two colorectal cancer research studies across Asia in collaboration with the National Taiwan University.

The company also released preliminary data from a study that showed its Nu.Q assay kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Read: VolitionRx unveils data showing its Nu.Q assays detect aggressive prostate cancer in men with 94% accuracy

Currently, VolitionRx develops and markets its cost-effective Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx’s Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

“I am delighted with the broad strength of new talent in our team, especially the growth in our research and development team in Belgium who are hard at work on the considerable project of turning our assays into robust products that can be used worldwide,” said CEO Cameron Reynolds in a statement.

Another recent achievement is its work on the so-called Bonn27 study which is being conducted with aid from the University of Bonn in Germany and involves the evaluation of 4,500 patients with 27 of the most prevalent cancers.

As part of a study with the University of Oxford, it also started proof-of-concept work to evaluate whether its easy-to-use Nu.Q blood-based tests can be used to diagnose endometriosis.

Read: VolitionRx completes blood sample collection as part of joint University of Oxford endometriosis study

For the three months ended June 30, Volition reported a net loss of US$4.6mln, or US$0.15 per share, compared with a net loss of US$3.5mln, or US$0.13 per share, in the year-ago quarter.

Last July, the company was awarded US$700,000 in non-dilutive funding from the Walloon Regional Government, which oversees the French-speaking region of southern Belgium, to continue its research into cancer diagnostic tests.

A month later, VolitionRx also raised as much as US$9mln in gross proceeds by completing a private investment in public equity, often called a PIPE deal, for 5 million shares of Volition common stock at a price of US$1.80 per share.

Read: VolitionRx enters into US$9mln private placement

Its pile of cash and cash equivalents rose in the second quarter to US$11.9mln, excluding the proceeds from its private placement, up from US$10.1mln at the close of last December.

VolitionRx shares closed 13% higher Monday to finish at US$1.91, but investors shaved off US$0.11 in after-hours trading.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Mon, 13 Aug 2018 16:49:00 -0400 https://www.proactiveinvestors.com/companies/news/202793/volitionrx-expects-its-nuq-blood-based-test-kits-to-generate-new-revenue-in-coming-quarter-202793.html
<![CDATA[News - VolitionRx unveils data showing its Nu.Q assays detect aggressive prostate cancer in men with 94% accuracy ]]> https://www.proactiveinvestors.com/companies/news/202777/volitionrx-unveils-data-showing-its-nuq-assays-detect-aggressive-prostate-cancer-in-men-with-94-accuracy-202777.html Life sciences company VolitionRx Ltd (NYSEAMERICAN:VNRX), which is focused on developing blood-based diagnostic tests for different cancers, announced preliminary data Monday from a study that showed its Nu.Q assay kits diagnosed men with aggressive prostate cancer with 94% accuracy.

Shares of VolitionRx shot up 14.2% to US$1.93 on the news.

The multi-center study collected blood samples from 84 men referred for prostate biopsies to three Belgian hospitals. The men were grouped by biopsy findings as having no cancer (most of whom had elevated prostate-specific antigen (PSA) levels), low-grade cancer or high-grade cancer. The samples were tested with a panel of five assays (the standard PSA blood test, two Nu.Q assays and two inflammatory biomarkers).

READ: VolitionRx enters into US$9mln private placement

The Volition panel of five assays, including the standard PSA test, identified 94% of aggressive cancers that required treatment.

VolitionRx’s Nu.Q assay compared favorably with just 33% identified by the PSA test alone, which relies on detection through high levels of prostate-specific antigen that may indicate the presence of prostate cancer.

"This is a very exciting outcome for us as we continue the development of our assays beyond colorectal cancer. The preliminary data from this study showed that Volition's panel of assays identified men with potentially lethal high-grade prostate cancer with much greater accuracy than PSA alone,” said Jake Micallef, chief scientific officer at VolitionRx.

“Based on this data, we believe that this test could assist clinicians in more accurate patient selection for prostate biopsy and treatment and substantially reduce the amount of unnecessary procedures in men with low-grade tumors or no tumor. The next step is to confirm these statistically significant findings in independent larger clinical trials," he added.

Prostate cancer is the second-leading cause of cancer death in men in the US after lung cancer.

Currently, prostate cancer is diagnosed through medical history, physical examination and by elevated levels of PSA in the blood. Men suspected of PCA are given a prostate biopsy to confirm the presence of cancer. However, most men with elevated PSA levels referred for prostate biopsy either have no cancer or have low-grade cancer which needs monitoring but not treatment.

READ: VolitionRx completes blood sample collection as part of joint University of Oxford endometriosis study

VolitionRx’s study suggests the Nu.Q assays may provide better risk stratification than that available using PSA tests for men with actual or suspected PCA, leading to better patient management and fewer unnecessary biopsies.

"A non-invasive test to help in the risk stratification of men with suspected or actual prostate cancer will be a major step forward in the management of this disease. The correlation of the panel blood test results with Gleason Score shows great promise in this regard. We will further investigate the data in relation to disease stage as well as additional factors used for pre-treatment risk stratification," said principal investigator, Professor Thierry Roumeguere, head of urological services, in the Erasme Hospital, in Brussels, Belgium.  

VolitionRx CEO Cameron Reynolds said the small trial is "important" because it "helps demonstrate once more the potential breadth” of the company’s technology.

“If these results are validated in larger trials, they will present a potentially significant new market opportunity. Volition's research team is continuing to develop our Nu.Q assays and we aim to launch products in 2019," said Reynolds.

Gaetan Michel, CEO of Volition's wholly-owned subsidiary, Belgian Volition SPRL, said the study was generously funded by the government of the Walloon Region.

VolitionRx develops and markets cost-effective, easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx's Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

The NU.Q Assay kits being sold by VolitionRx for colorectal cancer detection are the first of a planned series of kits being rolled out in the coming months. The Nu.Q holds promise and is being evaluated in Asia, the European Union and the US. The first data readouts and commercial launches are expected this year and into 2020.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 13 Aug 2018 10:37:00 -0400 https://www.proactiveinvestors.com/companies/news/202777/volitionrx-unveils-data-showing-its-nuq-assays-detect-aggressive-prostate-cancer-in-men-with-94-accuracy-202777.html
<![CDATA[News - VolitionRx completes blood sample collection as part of joint University of Oxford endometriosis study ]]> https://www.proactiveinvestors.com/companies/news/202595/volitionrx-completes-blood-sample-collection-as-part-of-joint-university-of-oxford-endometriosis-study-202595.html VolitionRx Ltd (NYSE AMERICAN:VNRX) has finished a three-year long collection of blood samples taken as part of a prospective study with the University of Oxford that aims to evaluate whether the company's easy-to-use Nu.Q blood-based tests can be used to diagnose endometriosis.

The collection of the blood samples from 350 patients over a period of more than three years was led by Professors Christian Becker and Krina Zondervan, co-directors of the University of Oxford’s Endometriosis Care and Research Centre.

Read: VolitionRx enters into US$9mln private placement

The Belgium-based company will now begin screening the blood samples using its Nu.Q. Assay kits and expects to report preliminary data from its investigation over the coming months.

“Volition owns patents in the detection of endometriosis using nucleosome assays and we look forward to investigating the use of Nu.Q technology in this large patient cohort,” said Dr Jake Micallef, Volition’s chief scientific officer, in a statement.

Early detection and diagnosis of endometriosis remain an important medical need for women. A leading cause of infertility, the condition can be extremely painful and is still diagnosed surgically by laparoscopy.

Read: VolitionRx's market in cancer detection expanding sharply with its Nu.Q product, says Maxim

“We are looking forward to the results of this study which very much complements our ongoing efforts at the Oxford Endometriosis CaRe Centre of identifying non-invasive biomarkers for endometriosis which we believe will be an essential step towards improving patient diagnosis and care,” said Professor Becker in a statement.

Currently, VolitionRx develops and markets its cost-effective, easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx’s Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

VolitionRx shares rose slightly on the NYSE American exchange to US$1.71.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Thu, 09 Aug 2018 09:24:00 -0400 https://www.proactiveinvestors.com/companies/news/202595/volitionrx-completes-blood-sample-collection-as-part-of-joint-university-of-oxford-endometriosis-study-202595.html
<![CDATA[News - VolitionRx enters into US$9mln private placement ]]> https://www.proactiveinvestors.com/companies/news/202484/volitionrx-enters-into-us9mln-private-placement-202484.html Life sciences company VolitionRx Ltd (NYSEAMERICAN:VNRX) announced Wednesday that it was raising around US$9mln in a private placement. The investors were not named.

The company said it will use the net proceeds of the private placement for product development, clinical studies, product commercialization working capital, and other general corporate purposes.

VolitionRx said it had entered into a “definitive agreement” with an “existing accredited investor” for a private investment in public equity, often called a PIPE deal, for 5 million shares of Volition common stock at a price of US$1.80 per share. According to terms of the transaction, the company is also offering a warrant to purchase an additional five million shares of Volition stock at an exercise price of US$3.00 per share payable in cash.

This will result in US$9mln in gross proceeds before the deduction of offering expenses. The warrant will have a term of one year from the closing date and be exercisable for a period of six months, commencing on the six-month anniversary of the closing date. The private placement is expected to close by August 10.

READ: VolitionRx's market in cancer detection expanding sharply with its Nu.Q product, says Maxim

VolitionRx develops and markets cost-effective, easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers. The tests are based on VolitionRx's Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

The market for the total NU.Q Assay kits being sold by VolitionRx for colorectal cancer detection may see its market go up after the American Cancer Society (ACS) recently issued guidelines to lower the age for screening because younger people are at greater risk of the disease.

The kit is the first of a planned series of kits being rolled out in the coming months. The Nu.Q holds promise and is being evaluated in Asia, the European Union and the US. The first data readouts and commercial launches are expected this year and into 2020.

Colorectal cancer is one of the most preventable cancers, yet it currently remains the least prevented form of cancer.

Shares of VolitionRx were 2.9% lower to US$1.70 in premarket trade.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Wed, 08 Aug 2018 07:45:00 -0400 https://www.proactiveinvestors.com/companies/news/202484/volitionrx-enters-into-us9mln-private-placement-202484.html
<![CDATA[News - VolitionRx's market in cancer detection expanding sharply with its Nu.Q product, says Maxim ]]> https://www.proactiveinvestors.com/companies/news/202041/volitionrx-s-market-in-cancer-detection-expanding-sharply-with-its-nuq-product-says-maxim-202041.html VolitionRx Ltd (NYSE:VNRX) will get a strong boost because its assay kit used to screen for colorectal cancer will probably see its market expand significantly and the test could be extended to include inflammatory and infectious diseases along with trauma, according to Maxim Group analyst Jason McCarthy.

Shares of VolitionRx recently traded around US$1.75 Wednesday afternoon and McCarthy reiterated a Buy rating and price target of US$6, more than triple its current value. The company markets easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers.

The market for the total NU.Q Assay kits being sold by VolitionRx for colorectal cancer detection may see its market go up after the American Cancer Society (ACS) issued guidelines to lower the age for screening because younger people are at greater risk of the disease.

READ: VolitionRx releases disease detection research kit to expand global product range

"Lowering the age for colorectal cancer screening substantially increases the market size for VolitionRx in the US," McCarthy wrote in a note to clients. "We view this as a positive for the company as the kits should help build awareness around Nu.Q platform."

The analyst added that changes by the ACS and shifting trends in colorectal cancer data may prompt "other agencies around the world could potentially change their guidelines as well, increasing the opportunity for VolitionRx, in our view."

The kit is the first of a planned series of kits being rolled out in the coming months. The Nu.Q holds promise and is being evaluated in Asia, the European Union and the US. The first data readouts and commercial launches are expected this year and into 2020.

--Recasts headline--

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Wed, 01 Aug 2018 13:26:00 -0400 https://www.proactiveinvestors.com/companies/news/202041/volitionrx-s-market-in-cancer-detection-expanding-sharply-with-its-nuq-product-says-maxim-202041.html
<![CDATA[News - VolitionRx releases disease detection research kit to expand global product range ]]> https://www.proactiveinvestors.com/companies/news/202022/volitionrx-releases-disease-detection-research-kit-to-expand-global-product-range-202022.html VolitionRx Ltd (NYSE:AMERICAN:VNRX) today released its first assay research kit (RUO), called the TotalNu.Q, expanding its product range beyond its usual blood-based tests for cancer.

The Belgium-based company said that the TotalNu.Q kit will be able to detect epigenetic modifications in lab samples, which reveals whether a person has disease or trauma.

It will be the first kit in its range to be released over the coming months by Active Motif, the company’s global sales and distribution partner.

READ:VolitionRx to take part in Bank of America Merrill Lynch's 2018 Health Care Conference

“These RUO kits will provide researchers throughout the world with a new way to explore epigenetic modifications in circulating cell-free nucleosomes across different diseases from clinical samples,” Active Motif Chairman Joseph M. Fernandez said in a statement.

The life-sciences company traditionally develops blood tests to help diagnose a range of cancers.

Its Nucleosomics platform identifies and measures nucleosomes, a unit of DNA, in the bloodstream to determine if a disease is present.

The company said that the kits released today are based on the same technology as its cancer-screening panels but will help them develop further services to expand the types of diseases that its kits can detect beyond cancer. The kits will offer a complete profiling solution from cell to serum.

“We expect that the RUO kits will provide an additional revenue stream beyond that from the expected commercialization of our blood-based tests for cancer,” Volition’s Chief Executive Officer Cameron Reynolds said.

Shares in Volition were down 5.49% to US$1.72 this morning.

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Wed, 01 Aug 2018 08:56:00 -0400 https://www.proactiveinvestors.com/companies/news/202022/volitionrx-releases-disease-detection-research-kit-to-expand-global-product-range-202022.html
<![CDATA[News - VolitionRx unveils three colorectal cancer detection studies in Asia ]]> https://www.proactiveinvestors.com/companies/news/200496/volitionrx-unveils-three-colorectal-cancer-detection-studies-in-asia-200496.html Life sciences company VolitionRx Ltd (NYSEAMERICAN:VNRX) is broadening the reach of its clinical trial program with the announcement of new agreements to conduct three large-scale colorectal cancer research studies across Asia.

The Asian studies will add to the momentum behind VolitionRx’s Nu.QTM colorectal cancer blood test, which is also being analyzed as part of big trials involving 45,000 Europeans and as many as 13,500 subjects in the US.

Volition today said it has signed agreements with National Taiwan University to conduct two large-scale studies, under the supervision of Professor Han-Mo Chiu, clinical professor with NTU’s department of Internal Medicine, and Professor Takahisa Matsuda, director of the cancer screening center with the National Cancer Screening Hospital in Tokyo.  

In addition to the research with National Taiwan University, VolitionRx has also signed an agreement for a 719-subject study to be run in collaboration with Professor Khay Guan Yeoh of the National University of Singapore.

Read: VolitionRX boss praises “strong progress” in 2017; thinks Nu.QTM panel could be new gold standard in cancer detection

All three studies are being conducted to test Volition’s proprietary Nu.Q platform for the detection and diagnosis of colorectal cancer.

The first trial will include 5,000 subjects with no symptoms of colorectal cancer and the second will evaluate up to 2,000 patients with colorectal cancer.

"The early detection of colorectal cancer could benefit the survival rate of patients significantly. There is a clear need for a product which not only has high accuracy but is also easy to use and affordable, such as a routine blood test,” Chiu said.

Keeping a Buy rating on the stock and a US$6 price target, Jason McCarthy, an analyst with Maxim group, considers Nu.Q blood tests a break-through given that the preferred methods of screening for colorectal cancer are currently colonoscopies in the US and fecal immunochemical tests in Europe.

"Non-compliance with screening using colonoscopy or fecal-based testing remains a significant issue and for VolitionRx represents a large opportunity for Nu.Q," McCarthy wrote in a recent note to investors.

VolitionRx develops simple and cost-effective blood tests designed to help diagnose a range of cancers. The tests are based on VolitionRx's Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream or in other bodily fluid.

Read: VolitionRx hails interim results of Danish trial for screening colorectal cancer

In the US, Volition is taking part in what is believed to be the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research Network with a cohort of over 13,500 subjects. Collection is underway and is expected to be completed in 2020.

Colorectal cancer is one of the most preventable cancers, yet it currently remains the least prevented form of cancer.

-- Updates story with analyst commentary --

 

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Tue, 10 Jul 2018 09:50:00 -0400 https://www.proactiveinvestors.com/companies/news/200496/volitionrx-unveils-three-colorectal-cancer-detection-studies-in-asia-200496.html
<![CDATA[News - VolitionRx secures US$700,000 in funding to continue developing cancer diagnostic tests ]]> https://www.proactiveinvestors.com/companies/news/199965/volitionrx-secures-us700000-in-funding-to-continue-developing-cancer-diagnostic-tests-199965.html VolitionRx Limited (NYSE:VNRX) has secured six-figure funding to continue its research into cancer diagnostic tests.

The company has been awarded US$700,000 in non-dilutive funding from the Walloon Regional Government, which oversees the French-speaking region of southern Belgium.

Starting in 2020, approximately US$200,000 of this funding will be repayable with annual installments over 12 years. A percentage of the company’s revenue may be payable over the same period, the company said in a statement.

The life sciences company develops blood tests to help diagnose a range of cancers. Its Nucleosomics platform identifies and measures nucleosomes, a unit of DNA, in the bloodstream to determine if a disease is present.

READ: VolitionRx first revenue from Nu Q technology is major milestone

“We are committed to the region and plan to recruit even more of the talented scientists in the area. This funding will support our continued research and development activities towards what we hope will be life-saving cancer diagnostic tests,” said CEO Gaetan Michel in a press statement.

Oppenheimer analyst Mark Breidenbach described the company as an “overlooked innovator in the cancer diagnostic space".

READ: VolitionRx initiated with US$7 price target and Outperform rating by Oppenheimer

Breidenbach sees the company launching its cancer screening tests in Europe in the first half of next year.

The tests could be introduced to the US market by 2021 if the company seeks the US Food and Drug Administration’s approval via a pre-market approval pathway.

The analyst gave the shares an Outperform rating with a price target of US$7.

Shares of the diagnostic company were up more than 8% to US$2.16 in Monday afternoon trading.

--Updated to reflect recent share price--

 

Contact Lenore Fedow at lenore@proactiveinvestors.com

 

Follow her on Twitter: @LenoreMariee

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Mon, 02 Jul 2018 09:08:00 -0400 https://www.proactiveinvestors.com/companies/news/199965/volitionrx-secures-us700000-in-funding-to-continue-developing-cancer-diagnostic-tests-199965.html
<![CDATA[News - VolitionRx price target is kept at $7 by Wall Street research house SeeThru Equity ]]> https://www.proactiveinvestors.com/companies/news/198210/volitionrx-price-target-is-kept-at-7-by-wall-street-research-house-seethru-equity-198210.html Another Wall Street analyst is bullish on the cancer diagnostics company VolitionRx (NYSE MKT:VNRX), with Amit Tandon, director of research at SeeThru Equity, coming out with a fresh research report in which he maintains a US$7 price target on the company’s stock.

VolitionRx, which markets easy-to-use Nu.Q blood-based tests to accurately diagnose colorectal cancer as well as a broad range of other cancers, has made “significant” progress since the last research note issued by SeeThru Equity in March.

“We see VNRX as a high-risk, high potential reward biotechnology company targeting a large and potentially transformative market in the healthcare/ biopharmaceutical space with its proprietary Nu.Q blood-based diagnostic tests,” wrote SeeThru Equity analysts.

On the list of Volition Rx’s achievements is its recent signing of a distribution deal with Active Motif for the license, manufacturing and sale of its research kits. Based on VolitionRx’s Nucleosomics technology for cancer diagnosis, these kits aim to help in drug development and treatment selection. They are intended to pave the way for researchers to look into epigenetic modifications in circulating nucleosomes, which stem from cancer and other inflammatory and infectious diseases.

“The commercialization of the kits should generate high-margin revenues in the short run while the company advances its diagnostics,” according to SeeThru Equity.

READ: VolitionRx initiated with US$7 price target and Outperform rating by Oppenheimer

The company’s financial picture also looks solid as it ended the first quarter of 2018 with US$14.3mln in cash on hand and just US$1.8mln worth of debt obligations. VolitionRx is burning about US$3mln in cash per quarter to advance its pipeline and keep its operations up and running.

Indeed, the development of a low-cost, non-invasive blood test for early cancer detection represents a tremendous opportunity for the company.

The company is in the middle of high-profile clinical tests ahead of the proposed launch of its first commercial products in Europe and Asia by the end of next year and in the United States sometime in 2020 or 2021.

At the University of Bonn, the results of a study involving 4,500 patients, which intend to show the potential reach of Nu.Q. beyond colorectal cancer, are set to be released by the end of the year

Read: VolitionRx hails interim results of Danish trial for screening colorectal cancer

In addition to colorectal cancer, VNRx’s Nucleosomics platform is being developed for advanced tests for lung cancer, pancreatic cancer, prostate cancer as well as endometriosis.

Another positive point, according to SeeThru Equity, is the way VolitionRx is looking into exploring licensing deals to allow its Nu.Q kits to be developed for the animal health market.

“In our view, the animal health market represents a significant opportunity given its large size and the relatively fast and low-cost regulatory process given that it is regulated by the USDA rather than the FDA,” the SeeThru Equity analysts commented.

The note from SeeThru Equity follows a similar one last month from Mark Breidenbach of Oppenheimer, who initiated coverage of VolitionRx’s stock with an Outperform rating and a US$7 price target.

Breidenbach expects the next 12 months to be “transformational” for VolitionRx as the non-invasive nature of its cancer-screening blood tests will make them popular.

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Mon, 04 Jun 2018 12:04:00 -0400 https://www.proactiveinvestors.com/companies/news/198210/volitionrx-price-target-is-kept-at-7-by-wall-street-research-house-seethru-equity-198210.html
<![CDATA[News - VolitionRx initiated with US$7 price target and Outperform rating by Oppenheimer ]]> https://www.proactiveinvestors.com/companies/news/197574/volitionrx-initiated-with-us7-price-target-and-outperform-rating-by-oppenheimer-197574.html VolitionRx Ltd (NYSE:VNRX) is closing in on a blood-based diagnostic for colorectal cancer that could encourage more people to seek out testing for the cancer, according to Mark Breidenbach, a closely-followed research analyst with Oppenheimer who is initiating coverage of its stock with an Outperform rating and a US$7 price target.

The non-invasive nature of VolitionRx’s blood test for colorectal cancer will make it popular compared to invasive colonoscopies, which are currently the most effective way to locate cancerous growths in the intestines.

Breidenbach expects the next 12 months to be “transformational” for the Belgian-based VolitionRx , which is knee-deep in conducting the largest-ever colorectal cancer screening study in collaboration with the National Cancer Institute’s Early Detection Research network with a cohort of over 13,500 subjects.

“Due to its non-invasive nature, we believe VolitionRx’s blood-based diagnostic could improve screening compliance, and the company’s innovative Nu. Q platform has generated compelling early data in colorectal cancer research,” Breidenbach wrote in a research note. 

Breidenbach describes the company as an “overlooked innovator in the cancer diagnostic space”.

READ: VolitionRX boss praises “strong progress” in 2017; thinks Nu.QTM panel could be new gold standard in cancer detection

VolitionRx’s Nu.Q platform looks for molecular signatures of cancer by focusing on nucleosomes in the blood. As cancer cells multiply, they are modified in a way that distinguishes them from healthy cells and the traits of this malignant disease present on the nucleosomes, which are analyzed by Nu.Q’s platform.

The early data from the NuQ screening panels suggests the company’s screening method could be commercialized successfully if it is validated in bigger studies.

Breidenbach sees the potential for VolitionRx to launch its cancer screen in Europe in the first half of next year and to seek the approval of the US Food and Drug Administration in the US via a pre-market approval pathway to allow for the drug’s introduction in the US by 2021.

READ: VolitionRx hails interim results of Danish trial for screening colorectal cancer

“If Nu.Q-based panels can achieve performance levels comparable to other non-invasive screening options, they could potentially be adopted as a standard front-line screening option, greatly expanding their market opportunity,” concludes Breidenbach.

VolitionRx were trading  7% higher to US$2.40 in afternoon trade.

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Wed, 23 May 2018 11:53:00 -0400 https://www.proactiveinvestors.com/companies/news/197574/volitionrx-initiated-with-us7-price-target-and-outperform-rating-by-oppenheimer-197574.html
<![CDATA[News - VolitionRx to take part in Bank of America Merrill Lynch's 2018 Health Care Conference ]]> https://www.proactiveinvestors.com/companies/news/196937/volitionrx-to-take-part-in-bank-of-america-merrill-lynch-s-2018-health-care-conference-196937.html Cancer test specialist VolitionRx Ltd (NYSEMKTS:VNRX) will participate in Bank of America Merrill Lynch’s 2018 Health Care Conference, which is being held Tuesday through Thursday of this week.

At the conference, which takes place at the Encore Hotel in Las Vegas, Scott Powell, chief financial officer of Volition America, will provide an update about the company’s key business, clinical, regulatory and operational achievements.

Earlier this year, VolitionRx hailed positive interim results from its huge trial in Denmark concerning colorectal cancer (CRC), which point to being able to detect early signs of the disease.

The ongoing study is in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark and involves 680 subjects from the Danish National CRC Screening Program.

READ: VolitionRx hails interim results of Danish trial for screening colorectal cancer

Meanwhile, in the US, VolitionRx is taking part in what is believed to be the largest ever colorectal cancer screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects.

Collection is underway and is expected to be completed in 2020.

In early trade, shares of VolitionRx were 2.9% higher at US$2.15.

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Mon, 14 May 2018 09:42:00 -0400 https://www.proactiveinvestors.com/companies/news/196937/volitionrx-to-take-part-in-bank-of-america-merrill-lynch-s-2018-health-care-conference-196937.html
<![CDATA[Media files - Q1 'very much a building quarter' for VolitionRx with growing cash reserves ]]> https://www.proactiveinvestors.com/companies/stocktube/9274/q1-very-much-a-building-quarter-for-volitionrx-with-growing-cash-reserves-9274.html Fri, 11 May 2018 14:16:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/9274/q1-very-much-a-building-quarter-for-volitionrx-with-growing-cash-reserves-9274.html <![CDATA[News - VolitionRx boosts cash reserves in 1Q, inks distribution deal with Active Motif ]]> https://www.proactiveinvestors.com/companies/news/196780/volitionrx-boosts-cash-reserves-in-1q-inks-distribution-deal-with-active-motif-196780.html Cancer test specialist VolitionRx Ltd (NYSEMKTS:VNRX) reported a slower first quarter cash burn rate on Thursday while growing cash reserves.

For the quarter ended March 31, the life-sciences company said that it increased its cash and equivalents to US$14.3mln, compared to US$10.1mln in the previous quarter.

"We have made great progress this quarter, moving our clinical assay development strongly forward and broadening our potential revenue base with our recently announced exclusive global license, manufacturing, sales and distribution agreement with Active Motif for a range of research use only kits," said Volition’s CEO Cameron Reynolds.

"We look forward to achieving our numerous upcoming clinical and commercial milestones, while continuing to keep close control on our cash burn, which has remained relatively stable."

VolitionRx has entered into a groundbreaking sales and distribution partnership with a rival life sciences group Active Motif that will pave the way for the sale of a range of research-use-only (RUO) kits based on its proprietary Nucleosomics technology starting in June.

READ: VolitionRx signs distribution agreement with Active Motif to sell research-use-only kits

These research-use-only kits are based on VolitionRx’s technology platform of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present.

Once they are distributed with the help of Active Motif, these RUO kits will provide researchers with new ways to explore changes in gene expression across different diseases from clinical samples.

The RUO kits are based on the same Nu.Q immunoassay technology as Volition's cancer screening panels and may be used to investigate a variety of clinical questions beyond Volition's core focus in cancer biomarkers.

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Thu, 10 May 2018 16:50:00 -0400 https://www.proactiveinvestors.com/companies/news/196780/volitionrx-boosts-cash-reserves-in-1q-inks-distribution-deal-with-active-motif-196780.html
<![CDATA[News - VolitionRx signs distribution agreement with Active Motif to sell research-use-only kits ]]> https://www.proactiveinvestors.com/companies/news/196662/volitionrx-signs-distribution-agreement-with-active-motif-to-sell-research-use-only-kits-196662.html VolitionRx Ltd (NYSEMKTS:VNRX), the cancer test specialist, has entered into a groundbreaking sales and distribution partnership with a rival life sciences group Active Motif that will pave the way for the sale of a range of research-use-only (RUO) kits based on its proprietary Nucleosomics technology starting in June.

These research-use-only kits are based on VolitionRx’s technology platform of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid- an indication that disease is present.

Once they are distributed with the help of Active Motif, these RUO kits will provide researchers with new ways to explore changes in gene expression across different diseases from clinical samples.

The RUO kits are based on the same Nu.Q immunoassay technology as Volition's cancer screening panels and may be used to investigate a variety of clinical questions beyond Volition's core focus in cancer biomarkers.

READ: VolitionRx hails interim results of Danish trial for screening colorectal cancer

“This is a fantastic opportunity for Volition and we expect that it will provide an additional revenue stream beyond that from the expected commercialization of our blood-based tests for cancer,” said Cameron Reynolds, Volition’s chief executive officer, in a press release.

VolitionRx’s cancer-screening tools have become quite popular, particularly in the area of colorectal cancer.

In the US, Volition is taking part in what is believed to be the largest ever colorectal cancer screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects.

Collection is underway and is expected to be completed in 2020. The idea is to build on the European studies to refine test performance and to present final data to the FDA before the study is completed.

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Wed, 09 May 2018 10:20:00 -0400 https://www.proactiveinvestors.com/companies/news/196662/volitionrx-signs-distribution-agreement-with-active-motif-to-sell-research-use-only-kits-196662.html
<![CDATA[News - VolitionRx price target raised to US$7 by microcap research house on high hopes for Nu.Q cancer screen ]]> https://www.proactiveinvestors.com/companies/news/193492/volitionrx-price-target-raised-to-us7-by-microcap-research-house-on-high-hopes-for-nuq-cancer-screen-193492.html VolitionRx Ltd (NYSEAMERICAN:VNRX), a Belgian company that develops easy-to-use blood-based tests to diagnose cancers, has considerable potential in the cancer-diagnostics market due to the accuracy of its tests and their low cost, according to a report from SeeThruEquity, a research house specialising in microcap and small-cap companies.

In a research note issued Tuesday, SeeThruEquity – which set a new US$7 share price target on VolitionRx -- lauded the cancer diagnostics group for its progress in both the clinical and corporate arenas. The group’s advances include the results of its first asymptomatic colon cancer study in February, which had 680 participants and showed high detection rates of stage 1 cancer and pre-cancers in colon cancer screening stemming from VolitionRx’s Nu.Q blood test.

Last year, VolitionRx also said it would participate in what is billed as the largest-ever colon cancer screening study, along with the National Cancer Institute and the University of Michigan, to validate its Nu.Q. cancer blood testing system for the US market; the study will be finished by 2020.

The company is also expected to bring in additional revenue with the distribution of research-use-only kits and has an announced an initial deal with a "large multinational pharmaceutical company."

VolitionRx ended last year with a cash position of US$10.1mln and raised US$8.4mln gross via its initial public offering, which is now closed. The money generated by its IPO is expected to advance its clinical activities through the middle of next year, assuming cash is spent at a rate of about US$3mln per quarter.

In early morning trade, shares in VolitionRx jumped 3% to $2.37.

 

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Tue, 20 Mar 2018 11:32:00 -0400 https://www.proactiveinvestors.com/companies/news/193492/volitionrx-price-target-raised-to-us7-by-microcap-research-house-on-high-hopes-for-nuq-cancer-screen-193492.html
<![CDATA[News - VolitionRx closes offering, raises US$8.4mln ]]> https://www.proactiveinvestors.com/companies/news/193107/volitionrx-closes-offering-raises-us84mln-193107.html Cancer testing firm VolitionRx Ltd (NYSE:VNRX) has raised US$8.4mln gross via its previously announced public offering, now closed.

It issued 3.5mln shares at US$2.40  a share.

"Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes," it said in the brief stock market statement Tuesday.

Oppenheimer & Co Inc. acted as the sole book-running manager.

Shares closed on Tuesday at US$2.34 each.

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Tue, 13 Mar 2018 16:30:00 -0400 https://www.proactiveinvestors.com/companies/news/193107/volitionrx-closes-offering-raises-us84mln-193107.html
<![CDATA[News - VolitionRX prices stock offering at US$2.40 a share ]]> https://www.proactiveinvestors.com/companies/news/192930/VolitionRX-prices-stock-offering-at-US-2.40-a-share-192930.html VolitionRx Ltd. (NYSE:VNRX) shares lost about one-fifth of their value Friday as the Belgium-based life sciences company announced plans to sell 3.5mln shares of its common stock in a public offering at a price of US$2.40.

The developer of blood tests designed to help diagnose a range of cancers said gross proceeds from the offering are expected to be about US$8.4mln before deducting for expenses.

VolitionRx also said it has granted the offering's underwriters a 30-day option to buy up to 525,000 additional shares to cover overallotments, if any. VolitionRx said it expects the offering to close on or about March 13.

READ: VolitionRx bolsters scientific advisory board with Harvard professor

Investors apparently were not pleased about the pending dilution of their holdings. They sent VolitionRx shares down 22% in premarket trading, to US$2.30 a share, and the pressure continued into the market open with shares down about 20% to US$2.38.

According to Yahoo Finance, VolitionRx currently has about 26.5mln shares outstanding.

The company said it intends to use net proceeds of the offering "for continued product development, clinical studies, product commercialisation, working capital and other general corporate purposes."

VolitionRx said a final prospectus supplement and an accompanying prospectus related to the proposed offering will be filed with the SEC and will be available on the SEC's website.

This story has been updated to include the number of shares offered and share price.

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Fri, 09 Mar 2018 14:40:00 -0500 https://www.proactiveinvestors.com/companies/news/192930/VolitionRX-prices-stock-offering-at-US-2.40-a-share-192930.html
<![CDATA[News - VolitionRx bolsters scientific advisory board with Harvard professor ]]> https://www.proactiveinvestors.com/companies/news/192772/volitionrx-bolsters-scientific-advisory-board-with-harvard-professor-192772.html Cancer diagnostic group VolitionRx Limited (NYSEMKT:VNRX) has bolstered its scientific advisory board with Dr Lee-Jen Wei, a professor of biostatistics at renowned Harvard University.

The professor's main area of research is developing statistical methods for the design and analysis of clinical trials.

READ: VolitionRX boss praises “strong progress” in 2017; thinks Nu.QTM panel could be new gold standard in cancer detection

He has worked closely with the pharmaceutical industry and regulatory agencies to aid both the development and evaluation of new products.

Professor Wei has developed numerous novel statistical methods used widely and is the author of more than 140 peer-reviewed publications.

Chaired by Dr Alan Colman, VolitionRx's scientific advisory board is tasked with strengthening the firm's clinical and commercial knowledge.

It's been a busy and successful spell for the group.

Its boss Cameron Reynolds said he reckons the life sciences group’s Nu.QTM colorectal cancer (CRC) test could become the new gold standard in detecting the deadly disease.

He said the company had made “strong progress” in 2017, and the hard work was rewarded earlier this week when the interim results from its huge – and ongoing – CRC screening trial in Denmark were published.

The results showed that by using just three assays (blood samples), when considered with subjects' ages and smoking histories, the Nu.QTM was able to detect 80% of Stage I CRC cases and 66% of High-Risk Adenomas (HRA) at 78% specificity, respectively

“We believe these are the first data to show high detection rates in a simple blood test, not only of early Stage I cancer, but also of the extremely important high-risk pre-cancerous adenomas,” the firm's chief executive said.

WATCH: VolitionRx reports positive interim results from Danish colorectal cancer study

“We believe that with further development, our Nu.QTM panel could form the basis of new colorectal cancer tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world.”

VolitionRx shares added 3.53% in New York to US$2.93.

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Wed, 07 Mar 2018 08:50:00 -0500 https://www.proactiveinvestors.com/companies/news/192772/volitionrx-bolsters-scientific-advisory-board-with-harvard-professor-192772.html
<![CDATA[Media files - VolitionRx reports positive interim results from Danish colorectal cancer study ]]> https://www.proactiveinvestors.com/companies/stocktube/8833/volitionrx-reports-positive-interim-results-from-danish-colorectal-cancer-study-8833.html Fri, 02 Mar 2018 11:27:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/8833/volitionrx-reports-positive-interim-results-from-danish-colorectal-cancer-study-8833.html <![CDATA[News - VolitionRX boss praises “strong progress” in 2017; thinks Nu.QTM panel could be new gold standard in cancer detection ]]> https://www.proactiveinvestors.com/companies/news/192527/volitionrx-boss-praises-strong-progress-in-2017-thinks-nuqtm-panel-could-be-new-gold-standard-in-cancer-detection-192527.html The boss of VolitionRx Limited (NYSEMKTS:VNRX) reckons the life sciences group’s Nu.QTM colorectal cancer (CRC) test could become the new gold standard in detecting the deadly disease.

Cameron Reynolds said the company made “strong progress” in 2017, and the hard work was rewarded earlier this week when the interim results from its huge – and ongoing – CRC screening trial in Denmark were published.

READ: Interim data suggests VolitionRX’s Nu.QTM can detect early signs of CRC

The results showed that by using just three assays (blood samples), when considered with subjects' ages and smoking histories, the Nu.QTM was able to detect 80% of Stage I CRC cases and 66% of High-Risk Adenomas (HRA) at 78% specificity, respectively.

“We believe these are the first data to show high detection rates in a simple blood test, not only of early Stage I cancer, but also of the extremely important high-risk pre-cancerous adenomas,” the chief executive said.

“We believe that with further development, our Nu.QTM panel could form the basis of new colorectal cancer tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world.”

Larger trials planned

The promising results will still need to be validated in larger and representative cohorts, and that will be chief among the company’s plan for 2018.

Results from a 4,300 subject study will hopefully be available in the second quarter of this year, while Volition hopes to kick off a 12,000-plus subject study in the second half which will form the basis of EU regulatory applications.

WATCH: VolitionRx reports positive interim results from Danish colorectal cancer study

Meanwhile, in the US, Volition is taking part in what is believed to be the largest ever colorectal  cancer screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects.

Collection is underway and is expected to be completed in 2020. The idea is to build on the European studies to refine test performance and to present final data to the FDA before the study is completed.

Just over US$10mln of cash in the bank

As for the numbers, Volition had cash and cash equivalents of US$10.1mln as of December 31 2017.

That’s enough money to keep it going for a little while yet, with the company burning through an average of US$3mln each quarter last year.

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Fri, 02 Mar 2018 08:16:00 -0500 https://www.proactiveinvestors.com/companies/news/192527/volitionrx-boss-praises-strong-progress-in-2017-thinks-nuqtm-panel-could-be-new-gold-standard-in-cancer-detection-192527.html
<![CDATA[News - VolitionRx hails interim results of Danish trial for screening colorectal cancer ]]> https://www.proactiveinvestors.com/companies/news/192279/volitionrx-hails-interim-results-of-danish-trial-for-screening-colorectal-cancer-192279.html VolitionRx Ltd (NYSE:VNRX) has hailed positive interim results from its huge trial in Denmark concerning colorectal cancer (CRC), which point to being able to detect early signs of the disease.

The ongoing study is in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark and involves 680 subjects from the Danish National CRC Screening Program.

"Using only a small panel of three assays and considering certain limited patient variables, these data demonstrate that we can identify early stage and pre-cancerous adenomas at a high level of accuracy in an asymptomatic screening environment," said VolitionRx chief executive Cameron Reynolds.

Reasonable costs..

Reynolds noted that the firm's tests use only a small amount of blood and could be added to routine blood screening at a reasonable cost.

"We believe these are the first data to show high detection rates in a blood test, not only of early Stage I cancer, but also of the extremely important high-risk pre-cancerous adenomas," he added.

"We believe that with further development, our Nu.QTM panel could form the basis of new CRC tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world."

Today's results showed just three assays, when considered with subjects' ages and smoking histories, produced an area under the curve (AUC) of 83% and was able to detect 80% of Stage I CRC cases and 66% of High-Risk Adenomas (HRA) at 78% specificity, respectively.

The results need to be validated in larger and representative cohorts, which Volition plans to do initially in a 4,300-subject study (the results of which are hoped to be available in the second quarter of 2018) and subsequently in a 12,000 plus double blinded study, using samples collected at 10 collaborating Danish hospitals.

The firm hopes to begin the 12,000 plus study in the second half of 2018, which will form the basis of EU product claims.

"In parallel, we are progressing towards obtaining a CE Mark for this panel so that the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test could be available for sale in the EU later this year," the firm added.

The largest ever colorectal  cancer screening study..?

Meanwhile, in the US, Volition is taking part in what is believed to be the largest ever colorectal  cancer screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects.

Collection is underway and is expected to be completed in 2020.

The idea is to build on the European studies to refine test performance and to present final data to the FDA before the study is completed.

Volition expects to define the final panel for the US front-line test within the next 18 months.

CRC is one of the most preventable cancers, yet it currently remains the least prevented form of cancer.

Shares were down 12.5% to US$2.80 in New York at the time of writing.

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Tue, 27 Feb 2018 08:48:00 -0500 https://www.proactiveinvestors.com/companies/news/192279/volitionrx-hails-interim-results-of-danish-trial-for-screening-colorectal-cancer-192279.html
<![CDATA[News - VolitionRx hails successful conclusion of Danish logistics study ]]> https://www.proactiveinvestors.com/companies/news/191172/volitionrx-hails-successful-conclusion-of-danish-logistics-study-191172.html VolitionRx Ltd (NYSE:VNRX) reported the successful conclusion of a logistics and pathway design study in Denmark aimed at seeing how a blood test for cancer could fit into the country's current screening system for colorectal cancer (CRC).

VolitionRx is developing easy to use blood-based tests to accurately diagnose a range of cancers.

The study showed it was possible to collect, process, gather and ship the blood test from all five participating hospitals to a central laboratory within 24 hours.

Plausible...

"We are delighted that the team in Denmark has completed the Logistics and Pathway Design Study and positively concluded that the logistics and feasibility of using a triage concept, where the triage test is used in addition to a fecal immunochemical test to screen for CRC, seems very plausible and could indeed fit into the current Danish screening pathway," said Cameron Reynolds, chief executive.

"We also further welcome their conclusion that the inclusion of the triage concept could be advantageous."

Many healthcare systems in Europe, including Denmark, are struggling to meet the increased colonoscopy demand following the implementation of solely fecal-based colorectal cancer screening programs.

"This study demonstrates that a colorectal cancer screening triage blood test may prove beneficial in other national screening programs," said the group.

HC Wainwright upbeat..

Last month, investment bank HC Wainwright repeated a 'buy' on the emerging cancer test group, highlighting that it was due to report results from a huge trial for its Nu.Q colorectal test imminently.

"In our view, the upcoming readout from the 680-subject trial is an important milestone for the company, which would enable the panel to be fine-tuned and tested in the following 4,300-subject trial in the current quarter," said analyst  Raghuram Selvaraju.

"We expect the frontline screening test to be finalized after the 4,300-subject trial and enter a 10,000-subject trial in 2Q18."

The broker says, alongside this, the firm aims to secure CE Mark for the screening test by the end of the third quarter 2018."

It reckons the test could be commercially launched in early 2019 in EU countries, which comprises roughly 150mln people eligible for CRC (colorectal cancer) screening.

Notably, Wainwright also says VolitionRx also expects to receive regulatory approval in Asia for the screening test shortly after EU approval.

"Particularly, Singapore Volition, a wholly-owned subsidiary of VolitionRx, has entered into a memorandum of understanding (MOU) with the National Taiwan University to conduct two large CRC research studies across the Asia Pacific region, totalling 7,000 patient samples.

"Both parties intend to sign a binding study agreement in the current quarter," said the analyst.

Shares in VolitionRx shed 5.17% to US$3.12 in New York.

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Mon, 05 Feb 2018 14:41:00 -0500 https://www.proactiveinvestors.com/companies/news/191172/volitionrx-hails-successful-conclusion-of-danish-logistics-study-191172.html
<![CDATA[News - VolitionRx results from huge cancer test trial due; HC Wainwright upbeat ]]> https://www.proactiveinvestors.com/companies/news/190778/volitionrx-results-from-huge-cancer-test-trial-due-hc-wainwright-upbeat-190778.html Investment bank HC Wainwright has repeated a 'buy' on emerging cancer test group VolitionRx Ltd (NYSE:VNRX), highlighting the group is due to report results from a huge trial for its Nu.Q colorectal test imminently.

"In our view, the upcoming readout from the 680-subject trial is an important milestone for the company, which would enable the panel to be fine-tuned and tested in the following 4,300-subject trial in the current quarter," said analyst  Raghuram Selvaraju.

"We expect the frontline screening test to be finalized after the 4,300-subject trial and enter a 10,000-subject trial in 2Q18."

The broker says, alongside this, the firm aims to secure CE Mark for the screening test by the end of the third quarter 2018."

It reckons the test could be commercially launched in early 2019 in EU countries, which comprises roughly 150mln people eligible for CRC screening.

Notably, Wainwright also says VolitionRx also expects to receive regulatory approval in Asia for the screening test shortly after EU approval.

"Particularly, Singapore Volition, a wholly-owned subsidiary of VolitionRx, has entered into a memorandum of understanding (MOU) with the National Taiwan University to conduct two large CRC research studies across the Asia Pacific region, totalling 7,000 patient samples.

"Both parties intend to sign a binding study agreement in the current quarter," said the analyst.

VolitionRX shares in New York eased 0.55% to US$3.59 - which is a long chalk from the target price of US$10.

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Mon, 29 Jan 2018 15:18:00 -0500 https://www.proactiveinvestors.com/companies/news/190778/volitionrx-results-from-huge-cancer-test-trial-due-hc-wainwright-upbeat-190778.html
<![CDATA[Media files - Cancer Diagnostics group VolitionRX looks ahead to 2018 ]]> https://www.proactiveinvestors.com/companies/stocktube/8583/cancer-diagnostics-group-volitionrx-looks-ahead-to-2018-8583.html Thu, 04 Jan 2018 10:02:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/8583/cancer-diagnostics-group-volitionrx-looks-ahead-to-2018-8583.html <![CDATA[News - VolitionRx eyeing 'breakthrough' 2018 as it completes Copenhagen trial ]]> https://www.proactiveinvestors.com/companies/news/189469/volitionrx-eyeing-breakthrough-2018-as-it-completes-copenhagen-trial-189469.html Emerging cancer test group VolitionRx Ltd (NYSE:VNRX) told investors it has completed a 680-subject trial for its Nu.Q colorectal cancer test, which should kickstart a year of milestones and successes.

In a letter to shareholders, group chief executive Cameron Reynolds wrote that he expects to report results from the test early next month.

"This study has given us the confidence to start the next stage with a study of some 4,300 subjects, the results of which we hope to complete by March 31, 2018," he added.

"We then plan to complete a large blinded 10,000+ subject study in the second quarter of 2018 to ensure that we have the data in multiple trials to back up our product claims this year."

The study was conducted in collaboration with the University of Copenhagen, and included 680 asymptomatic colorectal cancer screening subjects (including 100 cancers), and tested up to 30 assays including the largest number of Nu.Q markers tested so far.

Some of these markers will be taken into Volition's large European trials this year and the company expects that this will give it a strong indication for one or more US products.

In addition, Reynolds said the group expected to  obtain a CE Mark in parallel so that its colorectal cancer test will be registered for sale in the 28 European Union member states by September 30 this year.

"We believe that this represents a very large commercial opportunity for Volition with a total addressable market of approximately 150 million people of screen relevant age," he added.

Reynolds also noted that the CE would give the firm a head-start to commercializing in Asia where the addressable market is over 200mln.

VolitionRx is developing blood tests (requiring just a single drop) - called Nu.Q tests - to discover if someone has cancer,  a disease for which a simple blood test is not normally an option.

Early diagnosis is key in cancer and can not only prolong the life of patients, but also to improve their quality of life.

"We are proud of the accomplishments we have achieved thus far and look forward to what the future holds, I think 2018 will be a breakthrough year for Volition on several fronts," concluded Reynolds in the letter.

The company has also released a video detailing its achievements of 2017 and its plans for 2018. This can be viewed HERE...

Shares in New York eased 3.17% to US$2.75 each.

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Wed, 03 Jan 2018 09:33:00 -0500 https://www.proactiveinvestors.com/companies/news/189469/volitionrx-eyeing-breakthrough-2018-as-it-completes-copenhagen-trial-189469.html
<![CDATA[Media files - VolitionRx signs MoU with National Taiwan University for two large clinical studies ]]> https://www.proactiveinvestors.com/companies/stocktube/8355/volitionrx-signs-mou-with-national-taiwan-university-for-two-large-clinical-studies-8355.html Fri, 10 Nov 2017 15:00:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/8355/volitionrx-signs-mou-with-national-taiwan-university-for-two-large-clinical-studies-8355.html <![CDATA[News - VolitionRx surges after unveiling plans to conduct two massive clinical studies ]]> https://www.proactiveinvestors.com/companies/news/187101/volitionrx-surges-after-unveiling-plans-to-conduct-two-massive-clinical-studies-187101.html VolitionRx Ltd's (NYSEAMERICAN:VNRX) stock shot up after it signed a memorandum of understanding with the National Taiwan University to conduct two large clinical studies.

The studies will entail taking some 7,000 patient samples.

"The signing of this MOU is a good start for Volition in the Asia Pacific Region" said Dr Jasmine Kway, Volition's vice president of Asia. 

"We are fortunate and delighted to be working with a renowned institution and Professor Han-Mo Chiu, a prominent thought leader. This large-scale study will be low cost in line with Volition's other great value studies such as the 13,500-subject study in the US and the ongoing 30,000-subject prospective study in Europe and demonstrates our commitment to conducting large trials worldwide to drive the acceptance of our products," Dr Kway added.

VolitionRx said the first trial would be a large scale multi-country, multi-center and multi-ethnic study in the Asia Pacific region, including 5,000 asymptomatic colorectal cancer screening subjects.

The second trial will include up to 2,000 symptomatic colorectal cancer patients.

These studies are being conducted to test and validate Volition's proprietary Nu.Q platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes.

In a separate announcement, the company released its third quarter results in which it listed a slew of achievements and some upcoming milestones.

The latter include the selection of the panel for the company's front-line Nu.Q Colorectal Cancer Screening Test by the end of this year.

Also on its to-do list is the completion of the Logistics and Pathway design study that is currently in progress in Denmark, and the publication of an update on its progress using nucleosomics to purify or enrich nucleosomes of tumor origin.

"We have made fantastic progress this quarter, moving our clinical product development strongly forward in Asia, Europe and the US, and broadening our potential revenue base with our recently announced research kit sales,” said Cameron Reynolds, president and chief executive of VolitionRx.

READ VolitionRx lifted by cash infusion and first order for new range of "research use only" kits

“We have further expanded our talented scientific team, with four new hires to the R&D team, financially supported by the local government in Belgium." Reynolds added.

"We continue to announce large trials at very affordable costs in our efforts to gain worldwide adoption of our products. We look forward to achieving our upcoming clinical and commercial milestones, while continuing to keep close control on our cash burn, which has remained relatively stable," he concluded.

Cash and cash equivalents at the end of September stood US$13.84 million, compared with US$12.53mln a year earlier.

The company posted a net loss of US$3.89mln, equivalent to 15 cents a share, versus a loss the year before of US$3.48mln (15 cents a share).

Shares in VolitionRx rose to US$3.72 in the morning trading session from US$3.12 overnight.

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Fri, 10 Nov 2017 10:47:00 -0500 https://www.proactiveinvestors.com/companies/news/187101/volitionrx-surges-after-unveiling-plans-to-conduct-two-massive-clinical-studies-187101.html
<![CDATA[News - VolitionRx first revenue from Nu Q technology is major milestone ]]> https://www.proactiveinvestors.com/companies/news/184546/volitionrx-first-revenue-from-nu-q-technology-is-major-milestone-184546.html Emerging cancer test specialist VolitionRx Ltd (NYSE:VNRX) has been making good progress in recent weeks and Friday's news of first revenues from its Nu.Q platform represented a milestone.

The firm received an order for its clinical research use only (RUO) kits from a large, multinational pharmaceutical company, it told investors on the same day it received a cash infusion of US$1.5mln, via a loan and a grant to advance its research.

Shares have lifted over 8% since Friday in New York to where they stand now at US$2.97 each. Broker HC Wainright rated shares a 'buy' after the news.

"We note that these RUO kits allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes across a variety of clinical applications beyond cancers," said analyst Raghuram Selvaraju.

Recurring revenue stream potential..

"Importantly, if the assays become an indispensable companion diagnostic to another company’s therapeutic candidate, potential future licensing opportunities could generate recurring revenue streams in addition to the company’s planned commercialization of Nu.Q assays for colorectal cancer (CRC), in our view."

Two weeks ago, VolitionRx outlined its strategy for its colorectal cancer screening test, which it reckons is its largest near term commercial opportunity.

Aiming to launch test in Europe in 2018..

It is eyeing a launch of the diagnostic test in Europe in 2018, with a  panel chosen for its  Nu.Q colorectal cancer screening test for Europe in the fourth quarter of this year.

In the third quarter of 2018, CE Marking is expected to be completed, so the product could then be marketed in 28 European countries. The CE mark will also offer a regulatory platform to expedite approval in many Asian markets, VolitionRx said.

Selvaraju said this should provide a solution to the overwhelming compliance issue of patients foregoing available colorectal diagnostic and screening tools, and may potentially become the preferred option in colorectal cancer detection.

"We continue to expect the Nu.Q CRC triage test to be launched in the EU near term and start generating revenue for the company in 1Q18," he added.

What does the company do?

The firm is focused on developing blood tests - called Nu. Q tests - to discover if someone has cancer,  a disease for which a simple blood test is not normally an option.

The tests are based on the science of Nucleosomics, which identifies and measures nucleosomes in the bloodstream or other bodily fluid -  an indication that disease is present.

Early diagnosis is key in cancer and can not only prolong the life of patients, but also to improve their quality of life

US development also on track..

Volition America, a wholly-owned subsidiary of VolitionRx, is set to take part in a large multi-center CRC screening study funded by the U.S. National Cancer Institute's (NCI) Early Detection Research Network (EDRN).

A total of 13,500 samples would be tested in the study and all the data could take up to three years to be pooled together.

As reported previously,  VolitionRx will contribute around just $3mln towards the arrangement, as opposed to a $30-$40mln usual cost for a trial of this size.

"In our view, Nu.Q assays’ ability to detect precancerous polyps at a high rate of sensitivity may be crucial in improving patient outcomes, thus differentiating it from competing tests," noted HC Wainright.

What's it worth?

The broker says its price target of US$10 a share (over three times' where it is now) is derived from a market value of the firm at US$254mln, including  discounted cash flow-based enterprise value for Nu.Q assays, with a 15% discount rate and 2% terminal growth rate.

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Mon, 25 Sep 2017 11:26:00 -0400 https://www.proactiveinvestors.com/companies/news/184546/volitionrx-first-revenue-from-nu-q-technology-is-major-milestone-184546.html
<![CDATA[News - VolitionRx lifted by cash infusion and first order for new range of "research use only" kits ]]> https://www.proactiveinvestors.com/companies/news/184453/volitionrx-lifted-by-cash-infusion-and-first-order-for-new-range-of-research-use-only-kits-184453.html Shares in VolitionRx Ltd (NYSEMKT:VNRX) rose as the company received a cash infusion of US$1.5mln.

SOFINEX, a public organization focused on the internationalization of Walloon companies and encouraging exports throughout the world, provided US$1.2mln by means of a loan while the Walloon Region of Belgium has chipped in with US$294,000 non-repayable grant.

The US$1.5mln received is in addition to the US$947,000 in loans previously provided by Namur Invest over the last 12 months and is consistent with Volition's policy of securing funding without, where possible, diluting shareholders.

The purpose of the loan is to support the development of Belgian Volition's subsidiary, Volition America Inc, which announced in July its participation in a large 13,500 subject colorectal cancer screening study in the US.

This study is to be conducted in conjunction with the Great Lakes New England Clinical Validation Center funded by the National Cancer Institute's (NCI) Early Detection Research Network (EDRN). 

READ Cancer test group VolitionRx's US trial is huge result, says chief executive

"We are delighted with the financial support that we continue to receive from our local agencies SOFINEX and Namur Invest, as well as the Walloon Region, Belgium,” said Dr Gaetan Michel, chief executive officer of Volition's subsidiary, Belgian Volition SPRL.

“We are committed to the region and plan to recruit even more of the talented scientists in the area. This funding will support our continued research and development activities towards what we hope will be life-saving cancer diagnostic tests."  

Shares in Volition were up 2.2% at US$2.74 on Friday morning, also boosted by the announcement of its plans for a new range of clinical research use only (RUO) kits based on its proprietary Nucleosomics technology.

The company, best known for its Nu.Q blood tests to detect cancer, has already received an order for RUO kits from a large multinational pharmaceutical company.

The RUO kits use the same platform as Volition's cancer diagnosis panels but may be used for many other purposes, for example as an aid to drug development and treatment selection,Volition explained.

Volition aims to offer off-the-shelf kits initially with a total nucleosome assay in the first quarter of 2018, followed in the second quarter of 2018 by a range of kits initially developed for its own internal cancer diagnostic development programs. The RUO range will allow researchers to explore patterns of epigenetic modifications (inherited traits) in circulating nucleosomes across a broad range of clinical applications including cancers, inflammatory and infectious diseases.

"This is a very important milestone for Volition as it represents our first revenue from the Nu.Q platform," said chief executive, Cameron Reynolds.

“The RUO kits could be used to develop a companion diagnostic to a pharmaceutical company's therapeutic product, so could represent an additional potential revenue stream beyond the commercialization of our blood-based cancer tests on the same platform of assays. After the initial sale of the RUO kits, a significant licensing arrangement is possible if the assays become a crucial component of another company's product," Reynolds added.

Dr Mark Eccleston, Volition's business development director, said the company has received a lot of interest from potential collaborators "in the field of evaluating nucleosome profiles in a range of applications beyond Volition's core focus in diagnostics.

“Our suite of Nu.Q RUO assays will provide researchers with a complete solution for profiling cell free nucleosomes from cell to serum. This will raise the profile of our approach and broaden the application base beyond our current focus in cancer. The RUO kits will provide external validation of our technology and an expanded user base. We expect this to lead to future licensing opportunities from new clinical applications of our Nucleosomics technology," he said.

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Fri, 22 Sep 2017 10:23:00 -0400 https://www.proactiveinvestors.com/companies/news/184453/volitionrx-lifted-by-cash-infusion-and-first-order-for-new-range-of-research-use-only-kits-184453.html
<![CDATA[News - VolitionRx eyeing launch of colorectal test in Europe in 2018 ]]> https://www.proactiveinvestors.com/companies/news/184249/volitionrx-eyeing-launch-of-colorectal-test-in-europe-in-2018-184249.html VolitionRx Ltd (NYSEMKT:VNRX) has outlined its forthcoming strategy for its colorectal cancer screening test, which it reckons is the largest near term opportunity for the firm.

It is eyeing a launch of the diagnostic test in Europe in 2018.

The current 12 month plan sees a panel chosen for its  Nu.Q colorectal cancer screening test for Europe in the fourth quarter of 2017.

In the first quarter of 2018 the chosen panel will be subject to validation in a 4,300-subject trial using secured samples from Danish cohorts, already acquired by Volition's subsidiary, Belgian Volition SPRL.

The panel will be subjected to further validation in a blinded 10,000-subject trial in the second quarter.

In the third quarter of 2018, CE Marking is expected to be completed on the chosen panel, so the product could be marketed in 28 European countries.

The CE Marking also offers a regulatory platform to expedite approval in many Asian markets.

"We believe that the market for the frontline screening test represents the largest near-term opportunity for Volition, as there are 150 million Europeans of screening age," said Cameron Reynolds, VolitionRx chief executive.

"Our strategy for Europe is now in place using patient samples that have already been secured in our very large ongoing Danish trials.

He added: "We look forward to executing on our worldwide strategies and to the anticipated launch of our frontline test in Europe in 2018."

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Tue, 19 Sep 2017 17:00:00 -0400 https://www.proactiveinvestors.com/companies/news/184249/volitionrx-eyeing-launch-of-colorectal-test-in-europe-in-2018-184249.html
<![CDATA[News - VolitionRx Ltd granted four new patents ]]> https://www.proactiveinvestors.com/companies/news/184024/volitionrx-ltd-granted-four-new-patents-184024.html Cancer diagnostic group VolitionRx Ltd (NYSE:VNRX) has been granted four further patents relating to its proprietary Nu.QTM platform - strengthening its IP portfolio worldwide.

Volition now has five granted patents in the USA and eight more in other territories

Dr Jake Micallef, Chief Scientific Officer, said: "Our worldwide portfolio of granted patents that protects various aspects of Volition's Nu.QTM technology is growing.

"These most recent patents further solidify our market position in blood tests for circulating chromosome fragments from dead cancer cells and we continue to apply for additional patents in this area."

Chief executive Cameron Reynolds added that the patents "will further protect Volition commercially as we progress towards commercialization of the platform".

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Thu, 14 Sep 2017 16:52:00 -0400 https://www.proactiveinvestors.com/companies/news/184024/volitionrx-ltd-granted-four-new-patents-184024.html
<![CDATA[News - VolitionRx to work with world-renowned professor to secure large trials in a range of cancers ]]> https://www.proactiveinvestors.com/companies/news/182872/volitionrx-to-work-with-world-renowned-professor-to-secure-large-trials-in-a-range-of-cancers-182872.html Cancer diagnostics specialist VolitionRx Ltd (NYSEMKT:VNRX) has signed a three-year agreement to work with the renowned expert Professor Stefan Holdenrieder.

Professor Holdenrieder is the director of the Institute of Laboratory Medicine at the Technical University of Munich, Germany.

He will be the principal investigator on Volition's nucleosome (bundled DNA) projects, aided by several members of his team.

He currently serves as secretary of the International Society of Oncological BioMarkers; External Quality Assessment consultant for tumor marker ring trials at INSTAND e.V.; and associate editor of several international scientific journals.

"My main research focus is the development and evaluation of new biomarkers that are useful in cardiology, oncology and immunology. Blood-based biomarkers [biological marker] such as Volition's Nu.Q assays are involved in all of these important medical fields,” noted Professor Holdenrieder.

“Nucleosomes are involved in thrombogenesis, in immune reaction and have the potential to help in the detection and management of cancer," he added.

The Institute of Laboratory Medicine has a Biomarker Center for the validation of new technologies and has expertise in the methodical, pre-analytical and analytical evaluation of new biomarkers that may be useful for disease detection and patient management.

It also owns and operates a bio-bank of biological samples taken from a large cohort of individuals in particular, those with diverse cardiovascular diseases.

Volition's chief executive officer, Cameron Reynolds, said the professor would support Volition's analytical and pre-analytical research.

He would also assist the Belgium-based company's efforts to secure large trials in a range of cancers, including lung, pancreatic, prostate, colorectal, breast and ovarian.

Shares in VolitionRx were up 4.15 at US$2.55 in early deals.

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Wed, 23 Aug 2017 10:01:00 -0400 https://www.proactiveinvestors.com/companies/news/182872/volitionrx-to-work-with-world-renowned-professor-to-secure-large-trials-in-a-range-of-cancers-182872.html