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FDA Clears GenePOC Group B Streptococcus Assay, MDx Platform

NEW YORK (GenomeWeb) – GenePOC today said that it has received FDA clearance to market its molecular assay for detecting Group B streptococcus and its Revogene molecular diagnostics instrument in the US.

The test and instrument was launched in Europe earlier in the year.

The GenePOC GBS LB assay uses real-time PCR technology to detect GBS colonization from lim broth samples. In clinical studies, the assay had overall sensitivity of 95.9 percent and specificity of 95.5 percent, compared with standard culture, the company said. Revogene, a fully automated, standalone system, allows labs to run between one and eight samples at once.

"The GenePOC GBS LB test will fulfill the increasing market need for cost-effective automated and easy-to-use testing for the identification of antepartum Group B Streptococcus colonization," GenePOC CEO Patrice Allibert said in a statement. He added that the firm is working to submit a second assay for Clostridium difficile to the FDA in the near future.