VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company, has appointed Diagnostic Oncology CRO, LLC (“DXOCRO”) to undertake development and clinical validation studies for its Nu.Q® product portfolio in the United States.
DXOCRO will conduct large-scale finding studies across multiple sites in the U.S. using Volition’s Nu.Q® NETs and Nu.Q® Cancer tests to determine clinical utility in sepsis and cancer. Volition anticipates that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the United States Food and Drug Administration (the “FDA”) and allow the tests to be marketed in the U.S.
Sharon Ballesteros, U.S. Head of Quality and Development Process at Volition, said: “DXOCRO is a leading contract research organization specializing in the commercialization of diagnostic biomarker technologies. They are an ideal partner for us as we develop our FDA strategy in the United States.
“DXOCRO will spearhead both our clinical product development and our regulatory program in the United States, and seek to establish clinical utility for our Nu.Q® products. Through multi-site development studies, they will help us demonstrate how our Nucleosomics™ technology can directly benefit patients and support our application to the FDA’s Breakthrough Devices Program and a Pre-submission anticipated in 2023.”
Thomas Soriano, President and Chief Executive of DXOCRO, said: “We’re delighted to be working with Volition, providing support and acting as the company’s regulatory and clinical affairs team in the U.S. Volition’s technology has the potential to significantly improve patient outcomes in those diagnosed with sepsis or cancer. Through the conduct of Volition’s clinical validation studies, we hope to validate a broad range of potential Nu.Q® products and support Volition’s U.S. commercialization strategy.”
Volition is developing simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including cancer in both humans and animals.
