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

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.

Citing statistics from the US Centers for Disease Control and Prevention, Quidel said that between 10 percent and 30 percent of pregnant women carry Group B Streptococcus that can be transmitted to newborns during delivery, and CDC guidelines recommend all pregnant women be tested for infection between 35 and 37 weeks of pregnancy.

"We can now provide the hospital laboratories with another AmpliVue assay for fast, accurate infectious disease testing without the need for additional investments for expensive equipment," Quidel President and CEO Douglas Bryant said in a statement.

Clearance of the assay follows 510(k) clearance of Quidel's AmpliVue C. difficile assay a year ago. Both assays are now available for sale in the US and Europe.