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Quidel Receives CE Mark for Its AmpliVue™ Hand-Held Molecular Diagnostic Test for Clostridium difficile

Quidel Corporation announced today that it received CE mark for the AmpliVue C. difficile assay, its non-instrumented molecular test for the detection of toxigenic Clostridium difficile bacterial DNA. Detection of the pathogen is achieved using a hand-held fully contained detection cassette which utilizes lateral flow technology. C. difficile is frequently associated with antibiotic therapy and often causes diarrhea and inflammation of the colon.

"Clostridium difficile infections can be life-threatening and are therefore critically important to diagnose as soon as possible. Molecular testing offers greater sensitivity and faster turn-around-times compared to many other methods," according to Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel.

A recent study published in the Lancet(1) suggests that a majority of the hospital-based labs in Europe continue to use traditional methods such as immunoassays or cytotoxicity assays. These assays may either lack sufficient sensitivity or are difficult to perform and may require several days to yield results. The AmpliVue C. difficile assay will allow these labs to quickly implement a fast and sensitive molecular method without the purchase of expensive capital equipment.

"We are delighted to receive CE mark for our AmpliVue C. difficile assay," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "The AmpliVue C. difficile assay will allow those labs that have previously opted for traditional methods to offer a more sensitive molecular test for patients in their care."

The C. difficile assay is Quidel's first assay in the hand-held AmpliVue format, and is currently available for sale in Europe. Quidel also sells other CE Marked molecular tests in the Real-Time PCR format for Influenza A+B, hMPV, and RSV + hMPV.

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