FDA Clears Quidel's Group B Streptococcus Assay for Handheld MDx Platform | GenomeWeb

NEW YORK (GenomeWeb News) – Quidel said after the close of the market on Monday that the US Food and Drug Administration has cleared the company's AmpliVue Group B Strep Assay, the second assay to receive FDA clearance to run on the AmpliVue handheld molecular testing platform.

The Group B Strep Assay combines isothermal helicase-dependent amplification with Quidel's expertise in lateral flow technology to detect Group B Streptococcus from enriched broth cultures of specimens from antepartum women, the San Diego-based company said.

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