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VolitionRx says Nu.Q NETs test gets CE mark enabling clinical use in over 27 countries across Europe

Published: 10:15 31 May 2022 EDT

VolitionRx -
Through routine blood tests, Volition said its simple, low cost, accessible technology can detect NETosis, predict disease severity, and monitor its progression and response to treatment

VolitionRx (NYSE-A:VNRX) Limited said its Nu.Q NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in over 27 countries across Europe.

NETosis is a unique form of cell death characterized by the release of neutrophil extracellular traps, composed of decondensed chromatin, that trap and kill bacteria and viral particles. Although NETs play an important role in our immune system, excessive production can lead to tissue damage and, in severe cases, sepsis, shock, and death, the company said.

"NETosis has become a huge focus for medics in recent years, given elevated levels of NETs are associated with poor patient outcomes in a range of diseases, such as COVID-19, but also including sepsis and cancer,” Jake Micallef, chief scientific officer at Volition said in a statement.

READ: VolitionRx reports strong 1Q anchored by $10M milestone payment from Heska for Nu.Q Vet Cancer Screening Test

“As NETs contain nucleosomes, we believe that our Nu.Q NETs test is a groundbreaking diagnostic solution for the detection and monitoring of NETosis. With CE marking, it can now be used within European clinical settings to identify patients with a high level of NETs and allow physicians to rapidly triage these patients, then monitor their disease progression and response to treatment," he added.

Through routine blood tests, Volition said its simple, low-cost, accessible technology can detect NETosis, predict disease severity, and monitor its progression and response to treatment.

Gael Forterre, chief commercial officer at Volition commented: "The role of NETs in the progression of acute, chronic, and debilitating conditions cannot be understated. As the only analytically validated test for NETs, we believe that there is enormous potential for Nu.Q NETs to support clinical decision-making, enabling physicians to act quickly, and improve patient outcomes. We expect this to be a significant commercial opportunity for Volition."

"Achieving CE marking is a critical regulatory milestone for us. Nu.Q NETs is now registered for use in Europe in both ELISA (enzyme-linked immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay) formats. We are now gearing up for commercialization and expect to drive sales from the first half of 2023," he added.

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.

Contact the author at jon.hopkins@proactiveinvestors.com

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