FDA Gives Osmetech’s Cystic Fibrosis Genotyping Test a Thumbs Up
It can be used to screen adults as a method to detect the disease in progeny.
Osmetech received FDA clearance for its eSensor® Cystic Fibrosis Genotyping Test for use on the eSensor® XT-8 System. This multiplex test can be used for cystic fibrosis carrier screening for adults of reproductive age as an aid in screening offspring for cystic fibrosis. It may also be utilized 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 blood-thinning drug warfarin.
Osmetech expects further commercial progress in 2009 by expanding the eSensor XT-8 test menu to include an extended Warfarin Sensitivity Test panel that includes CYP 4F2, a CYP 2C9 Genotyping panel, a venous thrombosis panel of Factor V, Factor II and MTHFR, and a Respiratory Virus Pathogen panel.