NEW YORK (GenomeWeb) – VolitionRx announced today that it has received CE marking for its blood-based colorectal cancer assay NuQX001S, one of several assays the company intends to market together for cancer diagnosis.
The test is based on the company's Nucleosomics technology platform, which identifies and measures nucleosomes in the bloodstream. VolitionRx is developing a suite of NuQ ELISA assays and said that it aims to commercialize a test comprising four to six individual assays for clinical use in Europe next year.
With the CE mark, "[w]e are now able to sell this assay clinically in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway, and Liechtenstein — an area with a total population of nearly 600 million people including over 150 million of screening age," VolitionRx President and CEO Cameron Reynolds said in a statement. "We are currently in the process of CE marking other assays to finalize the panel for the anticipated European launch of our tests in 2016."
In addition to ongoing clinical studies in colorectal cancer, the firm is conducting trials of its NuQ assays in pre-cancerous colorectal adenomas, lung cancer, prostate cancer, ovarian cancer, and endometriosis. The company is also running a trial of an assay targeting 27 common cancers including melanoma, sarcoma, and urinary cancers.
Earlier this month, VolitionRx presented interim data from a 4,800-subject clinical study showing that its assays detected 81 percent of colorectal cancers with 78 percent specificity for both early- and late-stage cancers. The assay was also able to identify 63 percent of low-risk adenomas and 67 percent of high-risk adenomas.