Volition’s NuQ-5mc assay detects 75% of patients with colorectal cancer

Nov 8 2013

Initial study results demonstrate detection rate of 75% for colorectal cancer

VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, today announces the publication of preliminary data from an ongoing independent trial of one of its NuQ^® assays. Priv.-Doz. Dr. Stefan Holdenrieder will present a poster at the eighth CNAPS (Circulating Nucleic Acids in Plasma and Serum) congress in Baltimore, MD, USA, showing results from his third party study into the effectiveness of a single NuQ assay for detecting patients with colorectal cancers.

Dr. Stefan Holdenrieder, who coordinated the trial, is based at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn, Rheinische Friedrich-Wilhelms-Universität Bonn. He is an expert in the field of circulating nucleosomes, and is widely published, having authored over 70 journal papers and several patents.

The results from the 90 patient study demonstrate that Volition’s NuQ-5mc assay was able to detect 75% of patients with colorectal cancer (CRC) at 70% specificity compared to healthy samples. The results were validated in a second set of 113 people.

“These initial results are a promising indicator that blood based methylation levels are a valuable biomarker in the diagnosis of colorectal cancer” Dr Holdenrieder commented. “The sensitivity and specificity achieved in the NuQ-5mc trial is comparable to other single-biomarker cancer diagnostic tests such as the widely adopted PSA for prostate cancer.”

“To get such encouraging results from a single assay gives us a solid platform to build on in our larger trials with multiple markers,” said Dr Jake Micallef, Chief Scientific Officer of VolitionRx. “Our approach is to combine two or more assays, which have shown differentiation independently from our current suite of 21 validated NuQ® biomarkers, with the aim of significantly higher sensitivity and specificity than from single markers alone. This initial data is the first in a series of trials currently underway for colorectal cancer diagnosis. In addition to these exciting results from Bonn, we expect to be able to report on our ongoing trials in Mont Godinne (Belgium) later in the year and the completion of the first 1000 patients of our pivotal Danish study Q1 2014.”

The full results and methodology of the study have been submitted for publication.

Volition is carrying out several further clinical trials on the effectiveness of the NuQ assays as a cancer diagnostic tool:

• 3 ongoing multi-cancer studies at University Hospital in Bonn, Germany; including an 800 patient retrospective study and a 2,000 patient prospective study that involves patients with the 20 most prevalent cancers
• A 250 patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
• A 4,800 patient retrospective study and a 6,000 patient prospective study into colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark.