VolitionRx Limited (NYSEAMERICAN:VNRX) has revealed promising results from two proof-of-concept clinical studies of its coronavirus (COVID-19) triage test using its flagship Nu.Q test (normally used to detect cancer biomarkers) to predict the likelihood that a positive individual will develop complications and severe disease.
The Austin, Texas-based company said the results will be available soon on BIORXIV.ORG and focus on "circulating nucleosomes as potential prognostic markers for COVID-19 disease severity."
In a statement, corresponding author Professor Stefan Holdenrieder, who is director of the Institute of Laboratory Medicine, at the German Heart Center, in Munich said: "We tested two independent cohorts of COVID-19 positive patients with quantitative nucleosome immunoassays and found that nucleosomes were highly elevated in plasma of severe COVID-19 patients relative to healthy control subjects and that both histone 3.1 variant and citrullinated nucleosomes increased with disease severity.”
He added: “Given that the highest levels of nucleosomes were found in patients requiring artificial ventilation or extracorporeal oxygenation, we believe that nucleosomes could serve as a guiding biomarker for disease severity in COVID-19 positive patients."
"Nu.Q has shown correlation with more severe COVID-19 cases implying strong prognostic potential, and we are now focused on the completion of larger longitudinal studies that would be needed to support a potential COVID-19 product launch,” said Reynolds.
“If we continue to see positive results in these longitudinal studies, we aim to have a CE-marked product available on multiple platforms in 2020 and will look to launch a low-cost product that could be used in any laboratory worldwide as soon as possible thereafter," he added.
The studies conducted at University Hospital Liege, Belgium and the German Heart Center in Munich are aimed at confirming whether circulating nucleosomes could serve as a prognostic marker for COVID-19 disease severity. Volition's goal is to develop a prognostic test with nucleosomes as a biomarker to provide early insight into which COVID-19 positive patients require higher levels of monitoring including hospitalization, versus those who are less likely to develop serious symptoms.
"Whilst cancer remains our core disease focus, these results demonstrate the versatility of the Nu.Q platform and the range of applications for which these products can be leveraged to help increase diagnostic power. I am hopeful that our Nu.Q epigenetic toolbox may have potential to help doctors and patients in the COVID-19 pandemic," commented Dr Jake Micallef, who is the chief scientific officer at Volition.
"I believe it may also be helpful in other respiratory viral outbreaks including influenza and pneumonia, particularly given that current COVID tests are specific to strain or disease, whereas Nu.Q is not. I am also pleased that the Nu.Q test kits used by the teams in Liege and Munich performed extremely well on their own lab equipment. This bodes well for use of the kit in any future lab setting."
The science behind Nu.Q and COVID-19
Under normal circumstances, neutrophil extracellular traps (NETs) are formed by white blood cells to catch and trap invading viruses by ejecting chromatin materials. Viruses like SARS and pneumonia, though, are associated with a hyperimmune response that sees white blood cells eject massive amounts of NETs, which is damaging to the lungs.
VolitionRx is currently clinically testing whether elevated levels of neuroendocrine tumors (NETs) in the blood are predictive of complications arising from viral infections such as COVID-19.
Shares on Tuesday advanced over 8% in New York to $3.78 each.
---Updates for share price---
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive