January 01, 2020

A Texas A&M University researcher said a blood-based cancer screening test may be available for use in dogs this year.

But the company behind the technology, VolitionRx, warned in November that it was low on cash, had little income, and needed more money to avoid closing.

The proposed test depends on detecting elevated concentrations of nucleosomes, cell-free DNA fragments that circulate in blood. Dr. Heather Wilson-Robles, who is leading the research at Texas A&M, said the amount of nucleosomes in blood rise with inflammation, immune responses, and certain types of cancers.

Nucleosomes can be inert or functional, Dr. Wilson-Robles said. Many come from dead cells, especially neutrophils and other short-lived blood cells. Others defend the body by trapping bacteria, interacting with immune cell receptors, or regulating cell replication and DNA repair.

In a healthy animal, white blood cells secrete most of the nucleosomes present in blood, she said. But cancer cells also can release them, causing spikes in the volume of specific DNA fragments.

Dr. Wilson-Robles, an associate professor and chair of comparative oncology in the Small Animal Clinical Sciences Department at TAMU’s College of Veterinary Medicine & Biomedical Sciences, hopes her research can show consistency among the spikes. As the product develops, test kits based on enzyme-linked immunosorbent assays could give veterinarians results within an hour.

“So, you come in for your geriatric annual evaluation, and the lab suggests a spike,” she said. “Maybe we recommend doing additional diagnostics, and maybe you can find that bladder tumor that we didn’t know they had.”

Dr. Wilson-Robles said in November it was too early to describe the sensitivity of the test. But she hopes veterinarians can use the technology in-house to screen seemingly healthy dogs or monitor dogs in remission, which are included in her team’s studies.

She thinks her team can validate the assay in the first half of 2020 to create a veterinary-use screening test for dogs and gain approval from the Department of Agriculture, which regulates veterinary biologics. She anticipates that the test could be available in 2020.

Texas A&M agreed to conduct the research in exchange for a 12.5% stake in Volition’s veterinary products, according to company information. Most of Volition’s work focuses on cancers common in humans, such as colorectal, lung, prostate, and pancreatic cancer.

In Volition’s filing with the U.S. Securities and Exchange Commission for the third quarter of 2019—published in November for the period ending Sept. 30—Volition executives indicated the company was losing money, creating doubt whether it could survive another year without more income, loans, or investments. Volition had its first product revenue that quarter, when it started selling research use–only screening kits and analyzing diagnostic samples.

Along with stock purchases, a grant, and a loan, that income helped Volition finish the quarter with about $20 million in cash or equivalents, up from $18.5 million three months earlier. The company has had $86 million in losses since its inception, the filing states.

Volition’s SEC filing from November indicates the company plans to launch its human medicine products in Europe and Asia, followed by the U.S. and other regions. It also notes the trials in veterinary medicine and efforts to enter that market.

The report says the U.S. has the world’s largest veterinary market and has a well-defined regulatory pathway for veterinary diagnostics through the Department of Agriculture, which requires fewer and smaller clinical studies than the Food and Drug Administration process for human-use diagnostics.

“This generally allows a much faster route to revenue for veterinary products as compared to human products,” the report states.