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FDA Clears Osmetech’s Cystic Fibrosis Test

NEW YORK (GenomeWeb News) – Osmetech said today that it has received clearance from the US Food and Drug Administration for a genotyping test for cystic fibrosis using the company’s eSensor XT-8 System.

The eSensor Cystic Fibrosis Genotyping Test screens for cystic fibrosis gene carriers in adults of reproductive age, and functions as an aid in newborn screening and as a confirmatory diagnostic test for the disease in newborns and children.

The FDA cleared Osmetech's warfarin sensitivity test for use on the XT-8 system a year ago.

The company said it plans to expand the test menu for its eSensor XT-8 to include an extended warfarin sensitivity test panel, a CYP 2C9 genotyping panel, a venous thrombosis panel, and a respiratory virus pathogen panel.

Company CEO James White said in a statement that the company plans to commercialize its new tests globally, and that it will begin transitioning customers using its eSensor 4800 to the XT-8 system.

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