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Great Basin Submits 510(k) Application to the FDA for Shiga Toxin Direct Test

Upon FDA clearance, will be the only stand-alone molecular test to provide CDC-recommended identification of the high-virulence serotype O157 in conjunction with Shiga toxin-producing E. coli (STEC) detection

SALT LAKE CITY--(BUSINESS WIRE)--October 08, 2015--

Great Basin Scientific, Inc. (NASDAQ:GBSN), a molecular diagnostics company, announced today that the Company has submitted its Shiga Toxin Direct Test to the U.S. Food & Drug Administration (FDA) for 510(k) clearance following the successful completion of a clinical trial that met all of Great Basin's clinical objectives. Upon clearance, the test will be the only stand-alone molecular test to detect Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen.

The Centers for Disease Control (CDC) reports STEC is a leading cause of bacterial enteric infections in the U.S., and in 2009, issued a recommendation that all stools submitted for testing from patients with acute community-acquired diarrhea should be cultured for STEC O157. These stools should be simultaneously assayed for non-O157 STEC with a test that detects Shiga toxins or the genes encoding these toxins. Conventional laboratory culture-based testing for STEC can be laborious and time-consuming, taking 48-96 hours to prepare and process the tests. The CDC states that prompt, accurate diagnosis of a STEC infection is imperative to reduce further infection or kidney damage, and to determine the best course of care, as antibiotic therapy in patients with STEC infections might result in more severe disease.

Believed by Great Basin to be superior to alternative tests on the market, the Company's Shiga Toxin Direct Test offers true...


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