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Group B strep test receives 510(k) clearance, 8/15

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Great Basin Scientific announced the FDA clearance and commercial availability of its molecular diagnostic test for group B streptococcus.

The group B strep assay provides accurate results in approximately 90 minutes with a specimen from enriched LIM broth. By targeting a highly conserved region of the cfb (CAMP factor) gene, the molecular assay provides definitive identification and a more rapid diagnosis of the mother’s GBS colonization status compared to standard culture-based tests, which may take up to an additional 48 hours. These test results provide the physician with important information for making appropriate, timely therapeutic decisions to prevent the spread of disease to the infant during delivery.

The integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, capable of both low-plex and multiplex targets, and allows providers to diagnose and define a clear treatment path.

Great Basin Scientific, 801-990-1055

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