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Osmetech lands FDA nod for genetic cystic fibrosis test

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Osmetech Inc. received a regulatory nod to market a test to determine whether adults carry the gene that causes cystic fibrosis.

The London-based molecular diagnostics maker, which has operations in Maynard, said the eSensor Cystic Fibrosis Genotyping Test will join its warfarin sensitivity test as indicated uses for the company’s XT-8 eSensor platform.

According to the company, the XT-8 is a bench-top testing system with a built-in CPU that can make complex testing quicker. The warfarin test, which identifies potential sensitivity to the blood-thinning drug, received FDA clearance last year.

The current standard of care for cystic fibrosis screening involves laboratory analysis of blood samples taken from pregnant women and their partners. Cystic fibrosis is a genetic disorder that causes the body to produce thick mucus in the lungs, severely affecting the respiratory system.

Osmetech said the FDA clearance was likely a pre-cursor to winning approval to expand the XT-8 plaform to testing for the H1N1 Swine Flu virus, which it applied for in May.

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