Osmetech receives FDA clearance for cystic fibrosis test

By Lisa Kerner

Erie, Pa., Jan. 24 - Osmetech plc said it has received its 510(k) clearance from the Food and Drug Administration for its cystic fibrosis carrier detection test and its eSensor4800 DNA Detection instrument platform.

Osmetech expects to begin selling both products in the first half of this year, according to a company news release.

"Following the approval of the eSensor platform, we now look forward to progressing discussions with strategic partners who are looking for cost-effective and easy-to-use instrumentation and consumables to work on other complex assays both in the health care and non health care markets," James White, Osmetech chief executive officer, said in the release.

The next Osmetech molecular test targeted for FDA submission is the CYP 450 pharmacogenomics assay currently in development, the company said.

Cystic fibrosis is the most commonly inherited disease in the North American Caucasian population, with a carrier frequency of 1 in 25. About 1 million tests for cystic fibrosis are carried out annually in the United States, according to the news release.

Osmetech is a London-based health care diagnostics group.

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