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Great Basin Submits 510(k) Application to the FDA for

SALT LAKE CITY--(BUSINESS WIRE)--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.

“We are aggressively driving the development and commercialization of assays that provide small-to-medium size hospitals and labs with the easiest-to-use and most cost-effective molecular diagnostic platform available”

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...


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