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

Developed routine blood test Nu.Q to screen for blood, colorectal, lung and prostate cancers The test could replace expensive and invasive procedures like colonoscopies and biopsies Actively developing coronavirus triage test for infected patients to predict likelihood of severe complications What VolutionRx does: VolitionRx (NYSEAMERICAN:VNRX) is an epigenetics 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 fluids 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 blood, colorectal, lung and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. VolitionRx is also developing the technology as a screening tool for endometriosis and for veterinary uses as well. VolitionRx’s command and control center is in Isnes, Belgium, where 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 this work is the 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 the Nu.Q platform. The company has already tested Nu.Q to detect prostate cancer. Data from an 84-patient study showed its test kits diagnosed men with aggressive prostate cancer with 94% accuracy. In early 2020, VolitionRx re-engineered its Nu.Q assays to use a magnetic particle-based assay format for improved analytical and clinical performance. The upgrade also helps shrink the turnaround time of test results to 70 minutes from six hours.  How is it doing: VolitionRx, which receives financial support from Belgium regional governments, closed its first quarter ended March 31, 2020, with $12 million in cash and cash equivalents, which comes as it plans to release clinical data from its optimized bead-based assays in colorectal, lung and other cancers.  The company had results from a proof of concept study in December showing that a single pre-clinical Nu.Q cancer test boasts an impressive ability to detect with accuracy non-Hodgkins lymphoma (80%) and a mix of leukemia cases, including acute lymphocytic leukemia and acute myeloid leukemia (95%).  For 2020 and beyond, the company plans to advance its cancer trials in Europe, Asia, and the US - while also looking at entry into the veterinarian, as well as the coronavirus (COVID-19) diagnostics markets. It's subsidiar, Belgian Volition SPRL has been conducting its first large-scale lung cancer study using the Nu.Q test with the National Taiwan University. Preliminary data for the first 600 patient samples is slated for release in 2020.  Belgian Volition also has agreements with the university to conduct two large-scale colorectal studies across Asia and expects to finish them in 2020. It has also launched a second lung cancer study of the test in China, partnering with a Shanghai-based firm.  In Europe, the company and Gyros Protein Technologies AB won a $1 million EU grant to collaborate on developing a lung cancer blood test - actually 12 tests in all based on Nu.Q technology and Gyros Protein’s Gyrolab platform to profile circulating cell-free nucleosomes. The test will be used for triaging individuals testing positive in Low Dose CT lung cancer screening. VolitionRx is planning a similar triage test to weed out people who are less likely to have colon cancer.  The company recently concluded a study with Liege University Hospital in Belgium that showed the Nu.Q test is effective in discriminating both between lung cancer and healthy controls, and between lung cancer and Chronic Obstructive Pulmonary Disease (COPD). 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. Data are being collected from over 13,500 people in the US, a project to be completed in 2020. VolitionRx also sees a big opportunity for its Nu. Q tests in veterinary medicine. In fact, in April the company and Texas A&M University completed a proof of concept study of the test (called Nu.Q Vet) on two cancers common in dogs that showed a 70% detection rate.  The company and the university are also business partners. Texas A&M has a roughly 12.5% equity stake in VolitionRx’s subsidiary, Volition Veterinary Diagnostics Development LLC, but the school also collaborates on research projects like the Nu Q Vet study. VolitionRx is currently expanding the subsidiary with a $500,000 loan.  At the same time, VolitionRx is migrating beyond its primary line of work in cancer detection. It is collaborating with the University of Oxford to see whether Nu.Q tests can diagnose the painful ovarian disease endometriosis. To expand beyond organic growth, VolitionRx is turning to acquisitions. In early 2020, subsidiary Belgian Volition closed on the purchase of epigenetic reagent company Octamer GmbH for $725,000 in cash, stock, and a five-year royalty agreement. The strategic acquisition helps secure the supply of one of the key components of its Nu.Q tests - the recombinant nucleosome used as the calibrant.  COVID-19 triage test Meanwhile, like many medical firms around the world, VolitionRx is doing its part to help industry professionals, regulatory officials and governmental bodies as they combat and attempt to stabilize the coronavirus (COVID-19) pandemic through testing, therapies and treatments.  The company is actively developing a COVID-19 triage test using the Nu.Q test to predict the likelihood that a positive individual will develop complications and severe disease. It recently conducted a proof of concept study involving 34 COVID-19-positive subjects and 50 control subjects that produced promising results. And preliminary studies of infected patients are now underway in hospitals in Belgium and Germany, with results expected in the second quarter. VolitionRx also is working with collaborators to investigate whether the Nu.Q test can predict which patients with COVID-19 are most at risk by identifying those who will need hospitalization or respiratory support before they become critically ill. It would help maximize the best use of critical care beds, too.  Inflection points:  Advance development of COVID-19 triage test  Advance the clinical trial program for lung cancer Advance large-scale colorectal cancer trials in Europe, US, and Asia Finalize blood plasma sample pre-analytics for upgraded Nu.Q test Complete further clinical studies for Nu.Q Vet with the aim of launching product in 2020 What the boss says:  “We are an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health, “ VolitionRx CEO Cameron Reynolds has said. “This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. We believe the last decade of work and our extensive intellectual property portfolio puts Volition in a strong position to be a significant player in this field."