VolitionRx Inc (NYSE:VNRX) will unveil details of its commercial product launch in September and October, including what role its diagnostic test will play in the cancer screening programmes of specific countries.
Cameron Reynolds, chief executive, said having three CE marks for its biomarker assays now had cleared the regulatory path for its nucleosome-based NuQ tests.
A first NuQ blood test will be launched for colorectal cancer later this year in Europe and VolitionRx has already started the branding and labeling processes.
The aim is to have the product CE marked by the end of this year, so making it “potentially saleable in 2017 in all 28 EU countries."
Recent research has indicated results from the tests are the same regardless of when and how blood samples are taken due to the discovered stability of circulating cfnucleosomes.
In a recent study, an age-adjusted algorithm based in five biomarker assays detected 75% of high-risk colorectal adenomas and 86% of stage I colorectal cancers.
In the three months to June, VolitionRx reported a net loss of $2.9mln (US$1.9mln), or $0.13 per share. Cash and cash equivalents at the end of the period were US $14.5mln.
As well as colorectal cancer, VolitionRx is developing tests for pancreatic cancer, prostate cancer, lung cancer and Idiopathic Pulmonary Fibrosis.