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Quidel

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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