VolitionRx is focusing next on a massive European clinical trial of its new colorectal cancer blood test in the wake of promising preliminary results from a smaller study in Germany. Success in the coming months will help support the company's plans to pursue a CE mark in 2014 and FDA approval the year after.
Volition, which is based in Belgium and Singapore, disclosed on Nov. 7 that its NuQ-5mc blood-based diagnostic successfully detected 75% of patients with colorectal cancer in a 90-patent study in Bonn, Germany, with a 70% specificity versus healthy samples. That's comparable to other single-biomarker cancer diagnostic tests on the market, such as the widely used PSA test for prostate cancer, Volition said. Further testing validated the results in another 113 people, and the company presented those preliminary findings at the eighth annual Circulating Nucleic Acids in Plasma and Serum Congress (CNAPS) recently in Baltimore, MD.
What comes next? Volition Chief Scientific Officer Jake Micallef told FierceDiagnostics by email that the company is moving forward with a large independent clinical trial in Denmark. As part of that effort, researchers will use NuQ assays on 4,800 "initial retrospectively collected samples of individuals with colon cancers, precancerous polyps, competing conditions (such as irritable bowel syndrome and Crohn's disease) and asymptomatic healthy subjects." As well, he noted, sample collection will begin in 2014 for a 6,000-patient colorectal cancer screening study. Both are part of the same study, the company said.
Volition is bullish enough about its results that Micallef said it has submitted its Bonn data for publication to "high quality peer-reviewed journals." Execs plan submission of initial data from the company's Denmark study in the first half of 2014, he said.
Colon cancer can be hard to diagnose and often isn't spotted until it has become advanced, making it a challenge to treat. The competition between larger and emerging diagnostics companies alike is fiercely focused on developing tests that can identify the deadly disease sooner and with more certainty, outside of pursuing stool sample tests, which can be inconclusive, or colonoscopy-related biopsies. VolitionRx said it stands out from the pack because of its approach: developing simple blood-based tests to identify different kinds of cancer by identifying and measuring nucleosomes (gene regulating molecules) in the blood.
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