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BioHelix

This article has been updated from a previous version to correct the spelling of Quidel's AmpliVue technology.
By Ben Butkus

By a GenomeWeb staff reporter


NEW YORK (GenomeWeb News) – BioHelix today announced that the US Food and Drug Administration has given 510(k) clearance for its assay for the detection of herpes simplex virus.

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 key to the system is helicase-dependent amplification — an isothermal amplification method that is similar to PCR in many ways but does not require a thermal cycler and is therefore more suitable for in-field use.

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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