NEW YORK (GenomeWeb) – VolitionRx announced today that it received CE marking for its blood-based NuQ Colorectal Cancer Screening Triage Test, clearing it for commercialization in the European Union.
The test combines two previously CE marked assays — NuQ X001S and NuQ T003 — that are based on the company's Nucleosomics platform for identifying and quantifying nucleosome structural features such as histone modifications and variations, DNA methylation patterns, and nucleosome-protein adducts.
According to the company, the test has the potential to reduce colonoscopies by up to 25 percent while maintaining a nearly 97 percent colorectal cancer detection rate when combined with the fecal immunochemical test (FIT) score — the most frequently used first-line test for colorectal cancer in Europe.
"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," Louise Day, chief marketing and communications officer at VolitionRx, said in a statement.
VolitionRx said that 14 of the 28 EU member states have organized colorectal cancer screening programs, with an additional 10 states offering some form of publicly or privately accessible screening. The firm added that it has identified the five countries where it will initially launch the test, with rollouts in additional territories coming over the next five years.
A company spokesperson said that VolitionRx aims to begin discussions with US regulators about pursuing 510(k) approval for the test in mid-2017.