17 March 2014 – Parsortix FDA submission
The company has announced that it has made a submission to the FDA in the US for authorisation of its Parsortix cell separation system for sale as an in vitro diagnostic device in the US. The company hopes that it will receive FDA clearance by the end of Q3 although no guarantees can be made about the exact timing of authorisation. If successful, the company would be able to sell its Parsortix system to hospital pathology laboratories and other clinical customers in the US for the harvesting and molecular analysis of large cells such as circulating tumour cells from patient blood. As there are no such systems in the US this would give the company a market lead in the country – we retain our recommendation of BUY.