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 as well as sepsis Advancing coronavirus triage test for infected patients to predict likelihood of severe complications Built runway of $40 million in cash and cash equivalents What VolutionRx does: VolitionRx (NYSEAMERICAN:VNRX) is an epigenetics company that develops easy-to-use blood-based tests to accurately diagnose a range of cancers. It was founded in 2010 by Cameron Reynolds, who is its CEO.   The NYSE-listed company has designed a routine test called Nu.Q to screen for blood, colorectal, lung, and prostate cancers that reduces the need for more invasive colonoscopies and biopsies. VolitionRx also is advancing plans to develop Nu.Q as a method to monitor the treatment of sepsis.  The 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 the platform analyzes. VolitionRx’s command and control center is in Isnes, Belgium, where in early 2021 it opened a 10,000 square-foot manufacturing facility to produce, at large scale, all the key raw materials for its Nu.Q products, such as recombinant nucleosomes and antibodies. It also has a small laboratory at California State University with additional offices in Texas, London, and Singapore.  Its first commercial product is the Nu.Q Vet Cancer Screening Test -- which is being marketed in the US for use in older dogs. Meanwhile, VolitionRx is doing its part to help medical professionals, regulatory officials, and governmental bodies as they combat and attempt to stabilize and halt the coronavirus (COVID-19). The company is 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. VolitionRx is also 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.  How is it doing: In VolitionRx’s latest address to shareholders in March 2012, CEO Cameron Reynolds said the company is in its “strongest-ever financial position” to support and develop its diagnostic tests as it transitions from a research and development company to a commercial enterprise. The company currently has some $40 million in cash and cash equivalents, a cushion the company managed to double in a little over a year. ViolitionRx recently got an additional $4 million in non-dilutive funding from the Walloon Region and Namur Invest of Belgium. The company also kicked off 2021 by appointing four senior-level executives as part of its ongoing commercialization efforts for the Nu.Q platform, starting with the Nu.Q Vet products. The executive appointments include Terig Hughes as CFO, Dr Gaetan Michel as chief operating officer, Gael Forterre as chief commercial officer, and Dr Mark Eccleston as the company’s chief technology officer. In addition, VolitionRx appointed Kim Nguyen and Richard Brudnick as directors. Nguyen currently serves as head of human resource for Google Asia Pacific Pte Ltd. Brudnick currently serves as chief business officer and head of corporate strategy for Codiak BioSciences Inc.  In December 2020, VolitionRx launched the Nu.Q Vet Cancer Screening Test, which can be ordered by US veterinarians from Texas A&M University. The school has an equity stake in Volition’Rxs subsidiary, Volition Veterinary Diagnostics Development LLC. Vets can use the test during annual wellness checks for “older dogs" (those seven years and older) and for cases where there is a high suspicion of cancer.  Up to 50% of all dogs over the age of 10 develop cancer such as lymphoma in their lifetime. The test is also being eyed for use among younger dog breeds at high risk for developing cancer such as Golden Retrievers.  The company, which is in discussions with large multinational firms, said then that it planned to roll out the test nationally across the US over the next few months. In addition to the so-called “Texas beta launch,” VolitionRx is finalizing a beta launch of the Vet products for both Asia and Europe. The company is also focusing on using the Nu.Q platform on sepsis, a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues. Sepsis may progress to septic shock -- a dramatic drop in blood pressure that can lead to severe organ problems and death. VolitionRx’s Swiss-based partner Santersus AG recently reported data demonstrating that Nu.Q is an effective method for monitoring its highly selective plasmapheresis treatment targeting Neutrophil Extracellular Traps (NETs) in sepsis. NETs also play a role in COVID-19, autoimmune diseases, and cancer. Santersus has already begun the next phase of studies that are also using VolitionRx's Nu.Q assays, including the first human trial. VolitionRx also has engaged Diagnostic Oncology CRO LLC, the largest US contract research organization specializing in oncology purposed in-vitro diagnostic device clinical trials, to conduct a US regulatory clinical trial for Non-Hodgkin's Lymphoma (NHL). The company is also conducting a proof-of-concept study for the monitoring of treatment response for the most aggressive NHL cancer, diffuse large B-cell lymphoma.  VolitionRx's subsidiary, Belgian Volition SPRL, has been conducting its first large-scale lung cancer study using the Nu.Q test with National Taiwan University. The study involves 1,200 subjects receiving LDCT scans, including 1,000 with lung cancer. The collection commenced in the summer of 2019 and will be completed in May 2021. Meanwhile, a paper discussing the company’s Nu.Q Capture assay’s ability to detect certain modifications in the circulating nucleosomes in the blood of cancer patients has been published in the journal Scientific Reports. The paper, entitled "A Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes,” was authored by Volition Research and Development Director Marielle Herzog and focuses on mass spectrometry analysis. Inflection points:  Expect results from lung cancer study in Taiwan Launch beta test of Nu.Q Vet test in Asia and Europe Start US launch of Vet test Advance colorectal cancer trials in Europe, US, and Asia License technology to other firms for commercialization What the boss says:  "We made significant progress on many fronts throughout 2020, culminating in the launch of our first product, the Nu.Q Vet Cancer Screening Test in the fourth quarter. This was a pivotal moment for Volition, demonstrating that our platform has the reliability and reproducibility to launch in an independent laboratory," VolitionRx CEO Cameron Reynolds told shareholders in March's update. "Despite the persistence of the COVID-19 pandemic, we kept our laboratory operational throughout the year and completed the fit-out and opening of our new Silver One production facility in Namur, Belgium. I am proud of the way our team has adapted to the different world we find ourselves in and has kept working at full speed. It is their efforts and tenacity that has made possible these milestones and the many others that we achieved during 2020." Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham