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Quidel Expands Market for Flu Assay with Second Platform Approval

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Quidel said today that it has received 510(k) clearance from the US Food and Drug Administration for its Quidel Molecular Influenza A+B assay for use with the Cepheid SmartCycler PCR system.

The same assay received FDA clearance in December for use on Life Technologies' ABI 7500 Fast Dx thermal cycler. At that time, Quidel also received 510(k) clearance for its Molecular hMPV assay for detecting human metapneumovirus using the 7500 Fast platform (PCR Insider, 1/5/12).

The two assays were the first of Quidel's molecular assays to receive FDA clearance. In August, the company launched the Influenza A+B assay in Europe for use with both the SmartCycler and 7500 Fast after receiving the CE IVD Mark.

Quidel has been developing a number of real-time PCR-based assays for use on other companies' thermal cyclers as part of a three-pronged strategy to tackle the molecular diagnostics market.

The kits include "unique features that provide for simple transport and storage, ease of use, an attractive workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome," the company said in a statement.

In late April, Quidel President and CEO Doug Bryant noted during a conference call discussing the company's Q4 and full-year 2011 earnings that the company expects its next assays — for Clostridium difficile and respiratory syncytial virus — to enter clinical trials by the end this quarter (PCR Insider, 3/1/2012).

He also said at the time that Quidel had recently submitted an additional unspecified assay to the FDA for 510(k) clearance, and said that the company has seven additional real-time PCR assays in development.

Quidel's other molecular diagnostics plays include AmpliVue, its handheld, disposable, point-of-care platform that combines lateral flow detection technology licensed from Alere with isothermal helicase-dependent amplification technology from BioHelix; and Project Wildcat, a fully automated, PCR-based testing system that it is developing with researchers from Northwestern University and the NU Global Health Foundation.

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