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FDA Clears Quidel's MDx for Bordetella Pertussis

NEW YORK (GenomeWeb) – Quidel said after the close of the market on Wednesday that the US Food and Drug Administration has cleared the company's AmpliVue Bordetella Assay. 

The assay detects Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens from patients suspected of having a respiratory tract infection due to the bacteria, which causes whooping cough. 

Quidel's test is a self-contained handheld molecular diagnostic that requires no upfront DNA extraction and can generate results in about 75 minutes. The AmpliVue Bordetella Assay is CLIA-classified as moderately complex. It is the fifth assay in the AmpliVue format, the San Diego-based company said. In July the FDA cleared the AmpliVue GAS Assay for detection of Group A Streptococcus. In late 2013, it cleared the AmpliVue Group B Strep Assay, and in 2012, it cleared the AmpliVue C. difficile assay.

The AmpliVue technology was developed by BioHelix which Quidel acquired last year. Even before the acquisition, though, Quidel had been using the technology, dubbed helicase-dependent amplification (HAD), under a collaborative R&D agreement forged by the two firms in 2009. 

"We've shown that we can harness our proprietary HAD technology to develop fast, accurate, molecular diagnostics assays with a menu that matters to our customers," Quidel President and CEO Douglas Bryant said in a statement. "Longer term, we intend to leverage this technology for other molecular diagnostic applications that will be appealing to significant market segments and potentially to public health agencies worldwide."

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