About VolitionRx

VolitionRx Limited (Volition) operates as a multi-national epigenetics company powered by Nu.Q. Volition is developing simple, blood tests to help diagnose and monitor a range of life-altering diseases, including some cancers and diseases associated with NETosis, such as sepsis and COVID-19. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life. The tests are based on the science of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. The company has five key pillars of focus, all of which use the same proprietary Nu.Q platform to commercialize in different areas, such as Nu.Q Vet - easy-to-use cancer screening blood test for dogs and other animals; Nu.Q NETs - monitoring the immune system to save lives; Nu.Q Cancer - detecting cancer early to save lives; Nu.Q Capture - capturing and concentrating samples for more accurate diagnosis; and Nu.Q Discover - a complete solution to profiling nucleosomes. The company’s product development and manufacturing activities are centered in Belgium, with innovation and U.S. operations in California, and additional offices in Nevada, London, and Singapore, where it focuses on bringing its diagnostic and disease monitoring products to market. The company is dedicated to revolutionizing the diagnosis and monitoring of life-altering diseases by advancing the science of epigenetics. Imagine a world where diseases like cancer and sepsis can be diagnosed early and monitored easily using routine blood tests. That’s the world we’re trying to build by developing the company’s innovative family of simple, easy to use, cost-effective Nu.Q tests. The company’s patented Nucleosomics technology uses chromosomal structures called nucleosomes as biomarkers in cancer and other diseases: chromosomes consist of the genetic material (DNA) wrapped in a coat of proteins and other molecules. All the tests in the company’s portfolio detect various characteristic changes in nucleosomes that occur from the earliest stages of disease, potentially enabling early detection and a better way to monitor disease progression and the patient’s response to treatment. The company’s patented Nucleosomics technology isolates these circulating nucleosomes from the blood for quantification and analysis. Through its Nu.Q (short for nucleosome quantification) family of tests in the company’s five key pillars of focus, it aims to offer a new, convenient and cost-effective approach to the detection, diagnosis and monitoring of diverse diseases from a simple blood test. The company has five key pillars of focus: Nu.Q Vet, Nu.Q NETs, Nu.Q Cancer, Nu.Q Capture and Nu.Q Discover, all of which use the same proprietary Nu.Q platform to commercialize in different areas. Nu.Q Vet For example, findings from a clinical study conducted by Volition and Professor Wilson-Robles and the team at Texas A&M University, peer-reviewed and published in August 2022, reflect that Volition’s Nu.Q Vet Cancer Test detected 76% of systemic cancers ( including lymphoma, hemangiosarcoma, and histiocytic sarcoma) at 97% specificity versus control. Data presented at the European Society of Veterinary Oncology Congress suggests that Nu.Q Vet may also serve as a more sensitive measurement of both minimal residual disease and remission and could be a useful monitoring test for dogs with cancer. The company is conducting ongoing research regarding Nu.Q Vet include point of care platform (in partnership with the Heska Corporation), broadening the range of cancers detected, differential diagnosis, pre-analytics for the use of Nu.Q Vet in the feline population, and use of the Nu.Q platform in NETosis in canines. Nu.Q NETs - Monitoring the Immune System to Save Lives The company is working to develop tests that will identify people at high risk of poor outcomes/death caused by an immune system overreaction to sepsis, COVID-19 and other infections. The immune system consists of many different types of white blood cells with different functions. The most abundant of these white blood cells are neutrophils, which serve as a first line of defense. When neutrophils detect bacteria, viruses, injuries, or other threats, these cells produce Neutrophil Extracellular Traps (NETs), which are sticky webs made of long strings of nucleosomes that work to inhibit a perceived threat from spreading through the body. Sepsis—widespread tissue and organ damage triggered by an abnormal immune response to an infection—is an area of particular focus for the company’s research on NETs. Because NETs contain nucleosomes, the company’s proprietary Nu.Q nucleosome assays have been shown to detect NETs. Using the company’s Nu.Q nucleosome assays could enable the stratification of patients with a high level of NETs, allow physicians to rapidly triage these patients, and monitor their disease progression and response to treatment. In May 2022, the company’s Nu.Q NETs product was CE marked for the detection and evaluation of NETosis on two platforms (ELISA plates and i-10), enabling clinical use in more than 27 countries across Europe. In August 2022, the company appointed Diagnostic Oncology CRO, LLC (DXOCRO), a contract research organization specializing in the commercialization of diagnostic biomarker technologies, to spearhead its clinical product development and regulatory programs in the United States. DXOCRO is undertaking large-scale finding studies across multiple sites using its Nu.Q platform to determine clinical utility in sepsis and cancer. The company hopes the study will support an application to the FDA’s Breakthrough Device program. The first phase of the study focused on sepsis has been completed and an application to the FDA’s Breakthrough Device Program is expected to be submitted in the first half of 2023. Nu.Q Cancer - Detecting Cancer Early to Save Lives The company is developing a blood test for cancer. Nu.Q Cancer can become a routine blood test for multiple types of cancer, allowing doctors to check off an extra box along with other routine blood tests like cholesterol during an annual wellness visit. Nu.Q Cancer tests have further potential applications in clinical oncology beyond cancer detection. Being able to use epigenetic information from tumor cells’ nucleosomes could also help physicians select the best treatment for each patient, monitor their response and the disease progression. The company is investigating the potential use of Nu.Q Cancer tests in a range of cancers and clinical settings. Nu.Q Capture - Capturing and concentrating samples for more accurate diagnosis - Locating the needle in a haystack. Volition’s Nu.Q Capture program has several strands of technology which either essentially removes background noise, thereby amplifying the signal or looks to identify the signal in a novel way. This sample enrichment tool removes healthy nucleosomes, leaving an enriched sample of abnormal nucleosomes behind for further analysis. These nucleosomes contain tumor-specific DNA typos, epigenetic changes, and other biomarkers that when analyzed could potentially be used to diagnose a specific type of cancer or other medical condition, guide treatment selection, and monitor disease and treatment progress. Other strands of Nu.Q Capture technology involve isolating various chromatin fragments, including nucleosomes and transcription factors from plasma for analysis by mass spectrometry and next-generation DNA sequencing. The use of Nu.Q Capture technology in the field of transcription factors has led to the successful isolation of tumor derived transcription factor-DNA complexes from blood samples obtained from cancer patients. As transcription factor binding to DNA is cancer and tissue specific, this technology may, in principle, provide the basis for blood tests for cancer in general, as well as blood tests to identify the organ or tissue affected by cancer. Development is ongoing. Another novel method utilizing Nu.Q Capture and mass spectrometry was published in 2021 and demonstrated the detection and quantification of histone modifications present in the circulating nucleosomes in the blood of cancer patients. Nu.Q Discover - A Complete Solution to Profiling Nucleosomes Nu.Q Discover empowers drug developers and scientists through access to a range of state-of-the-art assays for rapid epigenetic profiling in disease, model development, preclinical testing, and clinical studies - from discovery to market ready. Intellectual Property Volition is developing clinical products based on the enrichment and analysis of epigenetically modified circulating nucleosomes using immunoassay, mass spectrometry, DNA sequencing and other methods. The company has used this position to build a growing, broad and strong patent portfolio covering the ability to profile the epigenetic environment surrounding circulating chromosome fragments from diseased cells, including the epigenetic signaling status of nucleosomes, DNA, and other epigenetic chromatin proteins. The company’s patent portfolio includes 34 patent families (plus three in-licensed families) and a total 97 patents granted related to its diagnostic tests (including veterinary applications), with 12 patents granted in the United States, 15 patents granted in Europe, and a further 70 patents granted worldwide. Additionally, the company has a total of 122 patent applications pending, worldwide. The company intends to continue its development of the Nucleosomics technologies and will continue to apply for patents for future product developments. The company’s IP strategy is to protect the technologies and gain market exclusivity with patents in Europe and the United States and in other strategic countries. The patent filings on the technologies underlying the company’s products should provide broad coverage for each product, including protection through at least 2043. Research and Development The company’s research and development expenses were $14.6 million for the year ended December 31, 2022. Government Regulations The company’s diagnostic products fall within the in vitro diagnostic (IVD) medical device category and are subject to FDA clearance or approval in the United States. Commercialization of the company’s future products in the clinical in vitro diagnostic (IVD) market (e.g. for patient diagnosis in hospitals, clinics, etc.) requires government approval (CE marking in Europe, FDA approval in the United States, and Chinese Food and Drug Administration (CFDA) approval in China). The company’s diagnostic products fall within the IVD medical device category and are subject to FDA clearance or approval in the United States. The company anticipates its tests will have to be cleared through the FDA’s premarket notification (510(k)), process, or its premarket approval (PMA) process. History The company was formerly known as Standard Capital Corporation and changed its name to VolitionRx Limited in 2011.