Osmetech PLC (AIM: OMH) said it has received US Food & Drug Administration 510(k) clearance for its eSensor Cystic Fibrosis Genotyping Test for use on the eSensor XT-8 diagnostic testing station.
The shares rose nearly 14 percent on the news in morning trade.
This multiplex test is used for cystic fibrosis carrier screening for adults, 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. The Warfarin Sensitivity Test is used as an aid in the identification of patients at risk for increased sensitivity to the widely used blood-thinning drug warfarin.
Osmetech expects further commercial progress in 2009 by expanding the eSensor XT-8 test menu.