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VolitionRx Gets CE Mark for NETosis Test

NEW YORK – VolitionRx, an Austin, Texas-based epigenetics firm, announced on Tuesday that it has obtained a CE-IVD mark for its Nu.Q NETs test for NETosis, allowing it to offer the assay clinically throughout Europe.

Clinicians can use Volition's test to measure NETosis, a form of cellular death characterized by the release of neutrophil extracellular traps (NETs), an overabundance of which can lead to tissue damage, sepsis, and death. The blood-based test can be run in both enzyme-linked immunoassay and automated chemiluminescence immunoassay formats, according to the firm.

CSO Jake Micallef said in a statement that elevated levels of NETs are associated with poor patient outcomes in a range of diseases, including COVID-19, sepsis, and cancer.

"NETosis has become a huge focus for medics in recent years," Micallef said. By gaining a CE-IVD mark for the assay, Volition's Nu.Q NETs can be used to identify, triage, and monitor European patients, he said.

The company is now gearing up for commercialization of the test in Europe, and expects it to contribute to revenues starting next year.

A company spokesperson confirmed via email that Volition obtained the CE-IVD mark under the now-obsolete In Vitro Diagnostics Directive. Europe's new In Vitro Diagnostic Regulation came into force on May 26. However, most tests holding CE-IVD marks obtained prior to the IVDR date of application will remain compliant for several years, as Europe transitions to the new regulation.

Volition maintains its R&D activities in Belgium, but has sites in California, Texas, London, and Singapore. It obtained a CE-IVD mark for a colorectal cancer screening test based on its epigenetic technology in 2017. In 2020, the firm also branched out into SARS-CoV-2 testing during the COVID-19 pandemic. Last year, the company raised $20 million via a public offering.