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Great Basin Scientific Submitted Shiga Toxin Direct Test to FDA for 510(k) Clearance

Great Basin Scientific, Inc., 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 sample-to-result testing with less than three minutes of hands-on time, no specimen enrichment step, and presents much higher sensitivity than either non-molecular or antigen-based rapid tests, thereby simplifying workflow for laboratory technicians and providing cost savings while facilitating better patient care. The Shiga Toxin Direct Test quickly detects Shiga toxin-producingE. coli – specifically stx1 and stx2 genes – in addition to identifying the serotype O157. E. coli O157 can lead to a life-threatening condition called hemolytic uremic syndrome (HUS), characterized by hemolytic anemia and renal failure. By including identification of O157 in the test, a laboratory can avoid running additional tests or expensive panels to get the definitive answers clinicians need for timely and accurate course of care, providing the means to avoid health complications that may result from misdiagnosis.

“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,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “We remain focused on expanding our menu, and we believe submitting our Shiga Toxin Direct Test for 510(k) – with breakthrough workflow and more answers than other stand-alone tests – is representative of our dedication to meet the market’s demand for simpler methods and a better overall solution to infectious disease diagnostics,” Mr. Ashton continued.

Once approved and commercially available, the Shiga Toxin Direct Test can be run on the same Great Basin analyzer used to perform Great Basin’s commercially available low-plex tests forClostridium difficile (C. diff) and Group B Streptococcus (GBS), and their multi-plex Staph ID/R Blood Culture panel currently in review by the FDA.

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