VolitionRx's novel cancer diagnostic test achieves CE marking as it prepares for launch across Europe

VolitionRx Limited has announced that the company achieved CE marking on its Nu.Q Colorectal Cancer Screening Triage Test on 28 December, 2016, paving the way for its expected launch across the EU

The novel blood test, developed at Volition’s laboratories in Belgium in conjunction with Hvidovre Hospital (University of Copenhagen), has demonstrated the potential to reduce colonoscopies by up to 25% while maintaining almost 97% detection of colorectal cancer when combined with the faecal immunochemical test (FIT) score.

The Nu.Q Triage Test is the first in a pipeline of cancer screening tests that Volition hopes to bring to market.

Speaking about the CE marking, Cameron Reynolds, CEO of Volition, said: “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. 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.”

Louise Day, Volition’s Chief Marketing and Communications Officer, said: “Being able to offer European healthcare systems a simple and easy to use blood test that 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 health care systems better serve patients. We have identified the first wave of European countries for launch and are pleased with the progress we are making.”

The most frequently used first line test for colorectal cancer screening across Europe is the FIT test. Patients with a positive score following FIT are then referred for colonoscopy. However, approximately 94.8% of people who test FIT positive do not have colorectal cancer.

This means that there are a significant number of unnecessary expensive and invasive colonoscopies performed, placing a severe burden on both the patient and the healthcare system. Now that it has achieved CE marking, European patients with a positive FIT score could subsequently be given the blood-based Nu.Q Colorectal Cancer Screening Triage Test and then only be referred for colonoscopy if the combined test results indicate that it is necessary; thus potentially reducing colonoscopy referrals by up to 25%.

There are organised colorectal cancer screening programmes in 14 of the 28 EU states with a further 10 states offering some form of public or privately accessible screening. Volition has identified the initial target governments for its launch in Europe and then intends to roll out the Nu.Q test across further territories as part of a 5 year plan.