VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company, has announced that its Nu.Q® NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in more than 27 countries across Europe.
NETosis is a unique form of cell death that is characterized by the release of neutrophil extracellular traps (“NETs”), 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.
Through routine blood tests, Volition’s simple, low-cost, accessible technology can detect NETosis, predict disease severity, and monitor its progression and response to treatment.
Nu.Q® NETs is the first biomarker approved to measure NETs for patient management. Its broad intended use as a diagnostic tool to aid the detection and evaluation of diseases associated with NETosis offers a substantial commercial opportunity, with Volition’s estimated Total Addressable Market in Europe, for sepsis alone, amounting to almost $6.5 billion on an annualized basis.
Jake Micallef, Chief Scientific Officer at VolitionRx explained: “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.”
Micallef added, “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.”
Gael Forterre, Chief Commercial Officer at VolitionRx added: “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.”
VolitionRx 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.