VolitionRx (NYSE-A:VNRX) Limited said it has appointed Diagnostic Oncology CRO, LLC (DXOCRO) to undertake development and clinical validation studies for its Nu.Q product portfolio in the US.
The diagnostics and monitoring company said DXOCRO will conduct large-scale finding studies across multiple sites in the US using Volition's Nu.Q NETs and Nu.Q Cancer tests to determine clinical utility in sepsis and cancer.
VolitionRx said it 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 (FDA) and allow the tests to be marketed in the US.
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“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,” Sharon Ballesteros, US head of quality and development process at Volition, said in a statement.
“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,” Ballesteros added.
DXOCRO is a contract research organization specializing in the commercialization of diagnostic biomarker technologies.
VolitionRx is focused primarily on human diagnostics and monitoring, but also has a subsidiary focused on animal diagnostics and monitoring. The company's research and development activities are centered in Belgium, with an innovation laboratory and an office in the US and additional offices in London and Singapore.
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