AUSTIN, Texas, July 14, 2020 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company applying its Nu.Q™ Nucleosomics™ technology to develop simple, cost effective blood-based tests for cancer and other diseases, today announced that results from two proof of concept clinical studies using its Nu.Q™ assays have been submitted for peer review and will be available on BIORXIV.ORG shortly. "Circulating Nucleosomes as potential prognostic markers for COVID-19 disease severity" .
Commenting on the results, corresponding author Professor Stefan Holdenrieder, Director of the Institute of Laboratory Medicine, German Heart Center, Munich, Germany 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. 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."
Cameron Reynolds, Chief Executive Officer of Volition commented, "Nu.QTM 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. 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."
The studies, conducted at University Hospital Liege, Belgium and the German Heart Center in Munich, Germany aimed to confirm whether circulating nucleosomes could serve as a potential prognostic marker for COVID-19 disease severity. Early identification and triaging of patients tested positive for COVID-19 who are the most likely to deteriorate and need critical care would enable both improved outcomes for patients and a more efficient use of critical care resources for healthcare providers. Volition believes that this is still very much an unmet need worldwide in fighting the impact of the pandemic.
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 and critical care resources, 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, Chief Scientific Officer of 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 laboratory equipment. This bodes well for use of the kit in any future laboratory setting."
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The Science Behind Nu.QTM and COVID-19
Volition announced in April 2020 that it was actively developing a COVID-19 triage test and had filed a novel patent for the utilization of its Nu.QTM epigenetic platform for the triaging of COVID-19 diagnosed individuals. Preliminary study results reported in May 2020 demonstrated an Area Under the Curve (AUC) for a single Nu.QTM assay of 98.7% patients diagnosed as COVID positive following a polymerase chain reaction (PCR) test, versus control subjects with a sensitivity of 100% at 94% specificity.
White blood cells help protect the body against infection. White cells engulf invading viruses and bacteria and produce antibodies against them. In addition, white cells also eject chromatin material out of the cell to form Neutrophil Extracellular Traps (NETs) which catch and trap invading viruses. In a respiratory infection, white cells migrate to the lungs to protect them from the virus.
However, Severe acute respiratory syndrome (SARS) and pneumonia are associated with an inappropriate hyperinflammatory response to the virus involving massive ejection of NETs into the blood by white blood cells which is highly damaging to the lungs. The ejected NETs material is made up of nucleosomes that can be detected in minute quantities using Volition's Nu.QTM nucleosome assays which Volition believes may, therefore, predict the progression of SARS-CoV-2 pneumonia and complications including Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients.
Volition has not yet successfully developed a triage test for COVID-19 and is in investigational stages only.
Volition is a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of NucleosomicsTM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. Volition is primarily focused on human diagnostics but also has a subsidiary focused on animal diagnostics.
Volition's research and development activities are centered in Belgium, with additional offices in Texas, London and Singapore, as the company focuses on bringing its diagnostic products to market.
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