Volition Achieves CE Mark for Nu.Q® NETs Test
VolitionRx Limited (VNRX) has announced the CE marking of its Nu.Q® NETs test for the detection and evaluation of NETosis, allowing clinical use in over 27 European countries. This test can detect NETosis through routine blood tests, offering significant commercial potential with a Total Addressable Market of approximately $6.5 billion for sepsis in Europe. The company expects to start commercialization in the first half of 2023. The test aims to support physicians in managing diseases associated with NETosis, including sepsis and COVID-19.
- Nu.Q® NETs test receives CE marking for clinical use in Europe.
- Potential market opportunity estimated at $6.5 billion for sepsis in Europe.
- Expected commercialization in the first half of 2023.
- Risks exist related to market acceptance of the Nu.Q® NETs test.
- Potential for competition and technological obsolescence in diagnostics.
to aid the detection and evaluation of diseases associated with NETosis
AUSTIN, Texas, May 31, 2022 /PRNewswire/ -- 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
Jake Micallef, Chief Scientific Officer at Volition 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. 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 Volition 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."
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. For more information about Volition's Nu.Q® technology go to: www.volition.com
Note to editor:
For more information about NETosis, watch our video or go to our Nu.Q® NETs webpage.
About Volition
Volition is a multi-national epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life. The tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid - an indication that disease is present. Volition is primarily focused on human diagnostics and monitoring but also has a subsidiary focused on animal diagnostics and monitoring.
Volition's research and development activities are centered in Belgium, with an innovation laboratory in California and additional offices in Texas, London, and Singapore, as the company focuses on bringing its diagnostic and disease monitoring products to market.
For more information about Volition, visit www.volition.com
The contents found at Volition's website address are not incorporated by reference into this document and should not be considered part of this document. The address for Volition's website is included in this document as an inactive textual reference only.
Media Enquiries:
Louise Batchelor/Debra Daglish, Volition, mediarelations@volition.com +44 (0)7557 774620
Investor Enquiries:
Scott Powell, Volition, investorrelations@volition.com +1 (646) 650 1351
Joseph Green, Edison Advisors, jgreen@edisongroup.com +1 (646) 653 7030
Safe Harbor Statement
Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, Volition's expectations related to the potential uses, benefits and effectiveness of its Nu.Q® NETs test, the size of Volition's addressable market for such test, Volition's ability to successfully commercialize such test platform, and expectations regarding Volition's ability to transition to a commercial products company, including its future financial performance. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including a failure by the marketplace to accept Volition's Nu.Q® NETs test; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and its intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring markets and their rapid technological change; downturns in domestic and foreign economies; and other risks identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
Nucleosomics™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All references to "$" refer to the legal currency of the United States of America.
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SOURCE VolitionRx Limited
FAQ
What is the significance of the CE marking for VNRX's Nu.Q® NETs test?
What is NETosis and how does the Nu.Q® NETs test relate to it?
When does VolitionRx expect to begin commercialization of the Nu.Q® NETs test?
What is the market opportunity size for the Nu.Q® NETs test in Europe?
What diseases can the Nu.Q® NETs test help monitor?
