Proactiveinvestors USA & Canada Gen-Probe https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Gen-Probe RSS feed en Tue, 23 Jul 2019 04:14:08 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - FDA approves Gen-Probe's prostate cancer diagnostic test ]]> https://www.proactiveinvestors.com/companies/news/83747/fda-approves-gen-probes-prostate-cancer-diagnostic-test-25023.html Gen-Probe (NASDAQ:GPRO) said Wednesday U.S. health regulators approved its diagnostic test Progensa PAC3 which is used to verify the need for repeat biopsies in men at risk of getting prostate cancer.

The company, founded in 1983 and with about 1,363 employees, makes molecular diagnostic products and services to diagnose diseases and screen donated blood.

Gen-Probe acquired worldwide diagnostics rights to the biomarker Prostate Cancer Antigen 3 (PAC3) gene from DiagnoCure (TSE:CUR) in 2003.

The FDA approval was backed by a clinical study launched in August 2009 and finished in May 2010. The study enrolled 495 men at 14 clinical sites. Gen-Probe submitted their premarket approval application to the FDA in August 2010.

In the clinical study, the PAC3 assay had a negative predictive value of 90 percent, meaning a negative PCA3 assay result predicted a negative prostate biopsy 90 percent of the time.

The PCA3 gene test – carried out through urine samples taken after a digital rectal examination – is highly over-expressed in more than 90 percent of prostate cancers.  The test is the first urine-based molecular diagnostic test for prostate cancer.

"Over-expression of the PCA3 gene is highly specific to cancerous prostate tissue," said John Wei professor of urology at the
University of Michigan Health System. 

"When evaluated with other risk factors, the Progensa PCA3 assay fills an important unmet clinical need by helping physicians
identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy."

Prostate cancer usually consists of several primary tumours located in the prostate. If left untreated, prostate cancer cells may
continue to grow and could spread to other parts of the body and produce secondary tumours.

San Diego, California-based Gen-Probe noted that the Progensa PCA3 assay is indicated for use along with other patient information to assist in the decision for repeat biopsy in men aged 50 or older who have had one or more previous negative prostate biopsy.

A negative PCA3 assay result is associated with a decreased likelihood of a positive biopsy. A prostate biopsy is needed to diagnose cancer, the company said.

The company said that the Progensa PCA3 assay should not be used for men with atypical small acinar proliferation on their most recent biopsy.

According to the American Cancer Society, prostate cancer is the second most common type of cancer found in American men.

About 241,000 cases were newly diagnosed in 2011, of which roughly 34,000 med died from the disease.

Shares were down 0.13 percent to $69.69 apiece Wednesday on the Nasdaq.

]]>
Wed, 15 Feb 2012 12:40:00 -0500 https://www.proactiveinvestors.com/companies/news/83747/fda-approves-gen-probes-prostate-cancer-diagnostic-test-25023.html
<![CDATA[News - Gen-Probe receives Health Canada approval for prostate cancer screening test ]]> https://www.proactiveinvestors.com/companies/news/79211/gen-probe-receives-health-canada-approval-for-prostate-cancer-screening-test-17333.html Gen-Probe (NASDAQ:GPRO) said Wednesday it has obtained regulatory approval from Health Canada for its molecular diagnostic test, Progensa PCA3, used to verify the need for repeat biopsies in men at risk of getting prostate cancer.

Gen-Probe acquired worldwide diagnostics rights to the biomarker Prostate Cancer Antigen 3 (PCA3) gene from DiagnoCure (TSE:CUR) in 2003.

The PCA3 assay predicts results more accurately than the traditional prostate-specific antigen testing method, said Gen-Probe.

According to studies, an elevated PCA3 score is associated with an increased likelihood of a positive biopsy.

"Receiving a Canadian regulatory license for the Progensa PCA3 assay is another important milestone in our efforts to help physicians and patients make better decisions about whether to conduct repeat prostate biopsies," said Gen-Probe CEO, Carl Hull.

The PCA3 gene test - carried out through urine samples taken after a digital rectal examination – is highly over-expressed in more than 90% of prostate cancers.  The test is the first urine-based molecular diagnostic test for prostate cancer.

Health Canada granted the medical device license based on an August 2009 clinical study performed on 507 men. The study concluded in May of last year, after which Gen-Probe submitted its license application to Health Canada in December 2010.

In Canada, the Progensa PCA3 test will be used alongside other patient information or risk factors to aid in the decision for repeat biopsy in men aged 50 or older, who have had one or more previous negative prostate biopsies.

The test is marked for sale in the European Union, while a regulatory application has been submitted to the U.S. FDA.

Prostate cancer usually consists of several primary tumours located in the prostate. If left untreated, prostate cancer cells may continue to grow and could spread to other parts of the body and produce secondary tumours.

According to the Canadian Cancer Society, prostate cancer is the most common type of cancer among Canadian men. In 2011, it is estimated 25,500 Canadian men will be diagnosed with prostate cancer, and 4,100 will die of it.

San Diego, California-based Gen-Probe, founded in 1983, makes testing products used for clinical diagnosis of human diseases and for screening donated human blood.

The company’s shares jumped 79 cents to $61.61 Wednesday morning on the Nasdaq exchange.

]]>
Wed, 17 Aug 2011 11:29:00 -0400 https://www.proactiveinvestors.com/companies/news/79211/gen-probe-receives-health-canada-approval-for-prostate-cancer-screening-test-17333.html
<![CDATA[News - Gen-Probe Acquires GTI Diagnostics for $53 Million in Cash ]]> https://www.proactiveinvestors.com/companies/news/75416/gen-probe-acquires-gti-diagnostics-for-53-million-in-cash-10929.html Gen-Probe (Nasdaq: GPRO), a maker of disease diagnosis products based in San Diego, announced today that it has acquired privately-held GTI Diagnostics for $53 million in cash.

GTI produces a number of immune system-related testing products, including ones that measure a patient's immune response to therapies for bleeding disorders.  Wisconsin-based GTI also produces the white blood cell detection products sold by Gen-Probe under the Lifecodes brand. 

"Acquiring GTI enables us to broaden and strengthen our transplant diagnostics business," said Carl Hull, Gen-Probe's CEO.

"In addition, the acquisition gives us access to growing coagulation and transfusion-related blood bank products that we can sell to our current customer base."

Excluding acquisition charges, which have not yet been estimated, Gen-Probe said it expects the deal to be slightly accretive to its 2011 earnings per share. 

The deal was financed by the cash Gen-Probe had on hand. As of September 30, the company had about $149 million of cash. 

Gen-Probe’s shares have edged up by 0.5% to trade at $57.86 as of 11:33 am EST.

]]>
Thu, 16 Dec 2010 16:37:00 -0500 https://www.proactiveinvestors.com/companies/news/75416/gen-probe-acquires-gti-diagnostics-for-53-million-in-cash-10929.html