Volitionrx Ltd (NYSE:VNRX) announced a new commercialization strategy for the US with its FY15 results. The company will seek a 510(k) approval in the US as an intermediate step to eventual PMA approval. This will allow for a quicker commercial launch of the NuQ colorectal test in the US, but would limit its marketing to “informing” a physician’s diagnosis instead of being a definitive diagnostic tool. The nearest-term revenues are in Europe, where a CE-mark approval and commercial launch are slated for late 2016.
A stepwise approval process
VolitionRx will be seeking US approval for the NuQ colorectal cancer test via a staggered process in which the initial CLIA waivered NuQ colorectal test is supplemented with a 510(k) marketing authorization. The company predicts that the 510(k) trial will require a fraction of the total patients needed for a PMA approval (eg 500 vs 10,000) and significantly less time (six months). The company plans to initiate the 510(k) trial by the end of 2016 and the PMA trial shortly after.
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