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--Great Basin Scientific, Inc. (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 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-producing E. 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 for Clostridium difficile (C. diff) and Group B Streptococcus (GBS), and their multi-plex Staph ID/R Blood Culture panel currently in review by the FDA.
About Great Basin Scientific
Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at www.gbscience.com.
This press release includes forward-looking statement regarding the Shiga Toxin Direct Test and its effects upon the Company. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization, including the Staph ID/R Blood Culture Panel mentioned herein; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2014. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.
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