AUSTIN, Texas, April 29, 2020 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced results from its first proof of concept study conducted by Texas A&M University ("TAMU"). At a specificity of 90%, a single Nu.Q™ Vet assay detected almost 70% of both Canine Hemangiosarcoma and Canine Lymphoma with Areas Under the Curve ("AUC") of 84.5% and 83.1% cancer versus healthy, respectively. These two cancers alone represent almost a third of all canine cancers.
A presentation regarding Volition Veterinary Diagnostics Development LLC is available to view here.
Commenting on the results, Dr. Heather Wilson-Robles, an Associate Professor at TAMU and Chief Medical Officer of Volition Veterinary Diagnostics said, "The proof of concept results in these two very prevalent canine cancers give us confidence to move forward with other Nu.Q™ Vet assays in our pipeline, and with the larger range of cohorts and trials we have collected and planned. Clearly, we still have work to do as this single assay did not detect one of the other top five canine cancers, Canine Osteosarcoma, which was the third cancer tested in this study. However, I am delighted to see such positive results in these two significant cancers and look forward to reporting further data over the coming quarters with additional Nu.Q™ Vet assays, this time tested on an automated platform."
Dr. Terry Kelly, Chief Scientific Officer of Volition America commented, "It is exciting to see such strong results from our first Nu.Q™ Vet study conducted at Texas A&M University Veterinary Hospital. It is also interesting to note the similar patterns of detection seen in both canine and human samples confirming that the Nu.Q™ platform does appear to be useful in more than just human diagnostics. As with human diagnostics, there are currently no accurate, simple, affordable cancer screening tests available in veterinary medicine and yet 25% of dogs will develop cancer at some stage of their life. I look forward to completing the planned trials and to launch our first Nu.Q™ Vet product in the U.S. that we expect to occur in 2020."
The U.S. is currently the largest veterinary market in the world with almost 70 million pet dogs and approximately 6 million cancer diagnoses each year. It has a clearly defined regulatory pathway via the USDA, requiring fewer and smaller clinical studies than the FDA process for human diagnostics which generally allows a much faster route to revenue for veterinary products as compared to human products.
A presentation regarding Volition Veterinary Diagnostics Development LLC is available to view here
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About the Study
The canine cancer samples (n=156, Hemangiosarcoma =44, Lymphoma = 69, Osteosarcoma =65 including all stages ) were taken from the National Institute of Health (Division of Cancer Treatment and Diagnosis Tumor Repository) and the controls were taken from 39 healthy controls canine volunteers at TAMU.
Hemangiosarcoma is a highly malignant cancer representing 5% of all non-cutaneous malignant tumors that develops almost exclusively in dogs. It can spread rapidly, causing tumors almost anywhere in the body. It is most often found in the dog's heart and spleen. Many times, it is in the advanced stage before it is diagnosed.
Canine Lymphoma is a cancer of a type of blood cell (lymphocytes) and lymphoid tissues and is one of the leading cancers in dogs representing more than 25% of all canine cancers.
Canine Osteosarcoma refers to the most common bone tumor found in dogs. Bone cancer can affect any breed of dog, but it is more commonly found in the larger breeds. It represents approximately 8% of tumors seen in dogs.
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 Nucleosomics™, 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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Media / Investor Contacts
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Safe Harbor Statement
Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to the timing, completion and delivery of data from clinical studies, the effectiveness of Volition's blood-based diagnostic tests as well as Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD or the veterinary markets; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
Nucleosomics™ and Nu.Q™ and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.
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