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FDA clears sale of group B strep test

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Quidel Corporation has received clearance from the FDA to market a hand-held diagnostic test for group B streptococcus in pregnant women, according to a press release.

“We are pleased to receive 510(k) clearance for our AmpliVue Group B Strep assay,” Douglas Bryant, president and CEO of Quidel Corporation, said in the release. “We can now provide the hospital laboratories with another AmpliVue assay for fast, accurate infectious disease testing without the need for additional investments in expensive equipment.”

The AmpliVue portable device utilizes lateral flow technology to detect group B streptococcus in patients, and is available for use in the United States and Europe.

According to the CDC, the rate of group B streptococcus infection among newborns in the first week of life has declined by 80% since an active prevention program was launched in the 1990s. CDC guidelines recommend that all pregnant women should get tested for group B streptococcus infection between 35 and 37 weeks of gestation.