FDA Clears Osmetech’s Cystic Fibrosis Test | GenomeWeb

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.

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