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FDA Clears Quest's C. difficile Molecular Test

NEW YORK (GenomeWeb News) – Quest Diagnostics said today that the US Food and Drug Administration has given 510(k) clearance to its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.

The test is from Quest's wholly owned business Focus Diagnostics and is for aiding in the diagnosis of C. difficile. Simplexa tests use real-time PCR to qualitatively detect viruses, bacteria, and other analytes, and the C. difficile test uses a proprietary chemistry to eliminate nucleic acid sample extraction, allowing hospitals and other laboratories to achieve test results in about one hour, Quest said.

The test is performed on liquid or unformed human stool samples to detect the toxin B (tcdB) gene of C. difficile, including NAP1. Focus launched the test in Europe during the second quarter of 2011.

In the US about 14,000 people die each year from C. difficile-associated diseases, Quest said, citing statistics from the US Centers for Disease Control and Prevention.

"Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene … are essential for identifying and treating this infection as well as containing its spread," Jay Lieberman, medical director of infectious disease for Quest and Focus, said in a statement.

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