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FDA Clears Quidel C. difficile Assay for Life Tech's QuantStudio Dx and 7500 Fast Dx PCR Instruments

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems Real-Time PCR Instruments to be marketed in the US, the companies jointly announced today.

The assay kit includes an extraction-free, three-step sample preparation process requiring no heat step, timed step, or centrifugation. The fast and easy direct-to-amplification procedure allows for results in less than 70 minutes, Quidel and Life Tech said.

In a statement, Quidel President and CEO Douglas Bryant cited statistics from the Centers for Disease Control and Prevention indicating C. difficile kills 14,000 people in the US annually and costs the healthcare system about $1 billion in excess treatment.

"For this reason, a fast and accurate diagnosis is vital to the patient's proper treatment and speedy recovery," Bryant said. "With the clearance of our C. difficile assay, we extend our Quidel Molecular product line beyond respiratory infections with products that address the needs of hospital laboratories in higher-volume settings."

Meanwhile, Life Tech's QuantStudio Dx is designed specifically for ease of use, with a six-color feature that allows for a multiplex of six targets in one reaction. Life Tech launched the instrument in Europe in the fall along with the C. difficile assay developed by Quidel, as GenomeWeb Daily News' sister publication PCR Insider previously reported.

The 7500 Fast Dx Real-Time PCR Instrument is a five-color real-time platform "that delivers the performance required for high-quality results in a 96-well format," the companies said, adding that the platform is FDA-cleared for diagnostic use with the CDC's H1N1 assay and Quidel's Molecular tests for Influenza A+B and human metapneumovirus.

The 510(k) clearance further extends Life Tech's presence in the diagnostics space, following its launch of the Pervenio Lung RS test for distinguishing high-risk from low-risk early stage lung cancer patients. Last month, it also received 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore HLA typing kits.

For Quidel, the 510(k) clearance of the C. difficle test is the second in the past two weeks it has received for its molecular diagnostic tests, following clearance of its Molecular RSV + hMPV assay.