Nucleosome-based Colorectal Cancer Diagnostic Gets CE Mark

January 3, 2017
Nucleosome-based Colorectal Cancer Diagnostic Gets CE Mark
Source: Eraxion/Getty Images

Belgian diagnostic test-maker VolitionRx announced that it received CE marking on its novel Nu.Q Colorectal Cancer Screening Triage Test. The novel blood test, developed in conjunction with Hvidovre Hospital at the University of Copenhagen, has the potential to reduce colonoscopies by 25% when combined with the results of the fecal immunochemical test (FIT) score, currently the most common screening method in Europe.

"This is a very exciting time for Volition as we are coming to market with a product that we believe meets a pressing and immediate need in many European countries,” said Cameron Reynolds, CEO. “This is easily our biggest achievement yet, and is the result of many years of work from our dedicated team. This milestone signals our transition from a research and development phase to a commercial one."

The blood-based test identifies nucleosome profiles whose signatures vary according to the type of cancer present. According to the company, the nucleosome profiles are derived from variations in four different features of nucleosomes: amino acid changes to the histones in the nucleosomes, chemical modifications to the histone molecules, chemical modification to the DNA in the histone molecules, and complexes formed by nucleosomes with other chromosome proteins. The test uses a well plate coated with antibodies that capture the nucleosomes in the blood. Once captured, the labeled antibodies are added to the wells, which generate a signal if epigenetic alterations are present. The brighter the signal, the more alterations are present.

Currently, the FIT is the most common first-line test for colorectal cancer screening across Europe. Patients with a positive score following FIT are then referred for colonoscopy, though nearly 95% of patients referred are found not to have colorectal cancer. The Nu.Q Colorectal Cancer Screening Triage Test could be used if a patient received a positive FIT score, with the combined results used to determine whether the patient should receive a colonoscopy. According to VolitionRx, the two tests used together could reduce unnecessary colonoscopies by as much as 25%.

“Being able to offer European healthcare systems a simple and easy-to-use blood test which can be used to triage FIT-positive populations for colorectal cancer has the potential to make a significant difference in many people's lives and to help healthcare systems better serve patients. We have identified the first wave of European countries for launch and are pleased with the progress we are making," said Louise Day, Volition's chief marketing and communications officer.

VolitionRx, which went public on the NASDAQ market in early October, has a stated goal of making their tests “as easy and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests.” The test for colorectal cancer is the first of many cancer detection diagnostics currently under development by the company.

×

Oops! Please type your email in the following format: [email protected]

You’re all set!
Thank you for subscribing to
Clinical OMICs Weekly
.