VolitionRx 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.
