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Quidel

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Life Technologies will distribute and sell Quidel's molecular diagnostic assays in Europe under an agreement announced today.

Quidel said late last week that it has received the CE Mark for the Quidel Molecular Influenza A+B real-time RT-PCR assay, the company's first commercial molecular diagnostic test.

Quidel recently submitted a 510(k) package to the US Food and Drug Administration for its first molecular diagnostic assay, a real-time PCR-based test for influenza A and B for use on Life Technologies' 7500 Fast Dx platform.

The company is eyeing a $760 million US market for its three molecular diagnostic programs: a handheld, assay platform; PCR kits for use on third-party thermal cyclers; and "Project Wildcat," an integrated sample-to-result molecular diagnostic system.

The platform will combine immiscible phase filtration sample prep with automated amplification and detection, and is expected to have initial applications in point-of-care HIV testing in remote and resource-poor areas of the world. The company also sees the platform being used for decentralized molecular testing in more developed countries.

The San Antonio-based firm also intends to file a 510(k) for clearance of the assay.

The clearance covers a respiratory viral test for both RSV and hMPV.

Quidel said that Diagnostic Hybrids' fluorescent in vitro diagnostic assays would complement Quidel's point-of-care diagnostics for infectious disease and reproductive health.

Quidel will fund and jointly develop with BioHelix assays to rapidly detect infectious pathogens in a non-instrumented, handheld format using BioHelix's isothermal amplification technology.

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