NEW YORK (360Dx) – Volition America today announced it has signed an agreement to participate in a multicenter clinical cancer screening trial aimed at validating a panel of biomarkers for colorectal cancer.
Volition America, a wholly-owned subsidiary of VolitionRx, signed the deal to participate in the trial with Great Lakes New England Clinical Validation Center.
The goal of the trial is to validate a biomarker panel that includes Volition's Nu.Q Colorectal Cancer Screening Test in a large asymptomatic population in support of regulatory approval in the US. The study sample collection is anticipated to take between two and three years, and Volution will contribute $3 million toward the public-private arrangement in installments over a three-year period, the firm said.
The study is funded by the US National Cancer Institute's Early Detection Research Network and will provide about 13,500 asymptomatic screening samples from people 50 years of age and above who have not previously undergone screening or diagnostic colonoscopy. About 4,700 samples have been collected, with about 9,000 more to be collected prospectively
Volition CEO Cameron Reynolds said in a statement that the study will be "invaluable" when it seeks approval for the Nu.Q test from the US Food and Drug Administration. "The public-private arrangement involves joint governmental and private funding and reduces our costs to $3 million, and we believe that it represents exceptional value for our money," he said.