Osmetech Gets FDA Clearance For Cystic Fibrosis Genotyping Test

Osmetech has received FDA 510(k) clearance for its eSensor Cystic Fibrosis Genotyping Test, for use on the eSensor XT-8 System. This multiplex test is used for: cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children.

This is the second FDA 510(k) cleared multiplex test the company has for use on the eSensor XT-8 System, and follows clearance of a Warfarin Sensitivity Test.

James White, CEO of Osmetech, said: This FDA clearance marks the start of the broadening of the menu of FDA cleared tests available to our growing base of eSensor XT-8 System customers. Our proprietary, multiplexed DNA eSensor technology allows for the rapid development of new tests which we plan to commercialise globally consistent with market demands.”

“We have been delighted with the excellent operational performance of our eSensor XT-8 System in the market and we will now transition our first generation eSensor 4800 cystic fibrosis carrier detection customers over to the eSensor XT-8 System, enabling them to benefit from its many advantages including greater ease of use and widening test menu,” he added.