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VolitionRx Signs on Diagnostic Oncology CRO for Clinical Studies of Cancer, Sepsis Tests

NEW YORK – Epigenetics diagnostics firm VolitionRx said on Monday that it has appointed Diagnostic Oncology CRO to conduct development and clinical validation studies for its cancer and sepsis tests in the US.

The contract research organization will run large-scale studies at several sites to determine the clinical utility of Volition's Nu.Q NETs and Nu.Q Cancer tests in sepsis and cancer, respectively. Volition aims to then seek clearance, authorization, or approval from the US Food and Drug Administration for marketing its tests in the US, pending subsequent studies investigating the tests' chosen intended use claims.

"DXOCRO is a leading contract research organization specializing in the commercialization of diagnostic biomarker technologies," Sharon Ballesteros, US head of quality and development process at Volition, said in a statement. "They are an ideal partner for us as we develop our FDA strategy in the United States."

Nu.Q stands for nucleosome quantification and is the company's core technology. It is used to screen for cancers by extracting and analyzing free nucleosomes, segments of DNA wound around histones that can be found at elevated levels in the blood of cancer patients, via an ELISA assay targeting histone H3.1. Volition has also developed a veterinary version of this cancer screening assay called Nu.Q Vet.

Nu.Q NETs targets neutrophil extracellular traps, which form when neutrophils extrude their chromatin to trap items like foreign bodies and cancer cells during an immune reaction.

The company recently secured a $1.5 million loan from Belgium's Namur Invest Capital Risk.