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Tag Archives: Great Basin Scientific—

Great Basin launches Shiga toxin direct test

Sept. 7, 2016—Great Basin Scientific has launched its Shiga Toxin Direct Test, which the company said is the only stand­alone test to provide the CDC’s recommended identification of the high-­virulence serotype O157 in conjunction with detecting Shiga toxin-­producing escherichia coli, or STEC, giving clinicians a definitive patient diagnosis to make timely decisions on the right course of treatment. The company ...

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Molecular staph blood culture panel lands 510(k)

April 8, 2016—Great Basin Scientific has received FDA clearance for its Staph ID/R Blood Culture Panel. The panel is a sample-to-result, automated, DNA multiplex assay for simultaneous identification of Staphylococcus aureus and Staphylococcus species directly from positive blood cultures in about two hours. The panel identifies coagulase-negative staphylococci such as S. epidermis that are the part of normal flora of ...

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

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.

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Great Basin lands clearance for group B strep test

May 6, 2015—Molecular diagnostics company Great Basin Scientific recently announced that the Food and Drug Administration has granted clearance for its molecular diagnostic test for group B Streptococcus. This is Great Basin’s second assay to be cleared by the FDA. The company’s first test, for Clostridium difficile, or C. diff, was approved in May 2012. Great Basin plans to launch ...

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Great Basin secures $9.5 million in funding, 3/13

March 2013—Great Basin Corp., a privately held molecular diagnostics company that develops sample-to-result solutions, has raised $9.5 million in series B funding. The funding was led by private investors and will be used to expand manufacturing, fund research and development, and expand global commercialization efforts.

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