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.