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FDA clears C. difficile assay kit

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Quidel Corp. and Life Technologies Corp. announced today that they have received 510(k) clearance from the FDA to market a new Clostridium difficile assay kit.

“Molecular diagnostic assays have become the gold standard for infectious disease testing in the clinical lab,” Ronnie Andrews, president of medical sciences at Life Technologies, said in a press release. “Molecular testing is the fastest-growing segment of the diagnostics market ...”

The Quidel Molecular Direct C. difficile Assay uses two instruments: the QuantStudio Dx Real-Time PCR and the 7500 Fast Dx Applied Biosystems Real-Time PCR — both developed by Life Technologies. Both reagents include refrigerated storage and do not require freezing. The assay kit prepares C. difficile samples in three steps, generating diagnostic results in 70 minutes or less, according to the companies. The instrument does not require heat, time step or centrifugation.

The 7500 Fast Dx Real-Time PCR instrument also has been cleared by the FDA for use with the CDC’s H1N1 assay and with the Quidel Molecular assays developed to test for influenza A and influenza B and human metapneumovirus.