VolitionRx: Big EU Trials On Deck
Edison | Nov 29, 2017 05:02AM ET
In September 2017, Volitionrx Ltd (NYSE:VNRX) announced its European development plan for the Nu.Q™ colorectal cancer (CRC) frontline screening test. It will run two clinical trials (of 4,300 and 10,000 samples), which are expected to initiate in Q118 and Q218, respectively, supporting an expected CE mark and launch in Q318. VolitionRx is also participating in a three-year, 13,500-person US clinical trial including Nu.Q™ assays to support a US launch.
European development plan
The two planned European clinical trials intend to use banked blood samples from Danish patients. The sets of samples will be constructed to include confirmed CRC patients, fecal immunochemical test (FIT) negative patients, and FIT positive patients who are CRC negative in ratios similar to those found in national screening populations. The first trial (4,300 samples) will be used to hone the final Nu.Q™ panel to be used in the larger 10,000 sample trial and to be used for CE marking.
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