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Great Basin Scientific Completes Clinical Trial for Stool Bacterial Pathogens Panel
Date : 11/08/2016 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : NO^GBSN (GBSN)
Quote : 0.0602 0.0 (0.00%) @ 2:05AM
Great Basin Scientific Completes Clinical Trial for Stool Bacterial Pathogens Panel
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Great Basin Scientific, Inc. (USOTC:GBSN)
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Today : Tuesday 8 November 2016
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Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, announced today the successful completion of the clinical trial of its second multiplex panel – the Stool Bacterial Pathogens Panel. This is the first of two trials the Company has completed in 2016 and demonstrates the Company’s commitment to expand its product menu of sample-to-result assays to diagnose infectious disease. The Company will seek 510(k) clearance from the Food and Drug Administration (FDA) as well as CE marking, and if cleared, the Company believes that the Stool Bacterial Pathogens Panel will provide significant assistance to hospitals and laboratories in detecting common bacterial agents, including food borne pathogens, that are suspected of causing acute gastroenteritis in patients.
Great Basin Scientific provides both low-plex and multiplex testing on a single system. The Company’s Stool Bacterial Pathogens Panel will simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli species (stx1 and stx 2, O157), and Camphylobacter species (C. jejuni and C. coli).
“We are excited about the on-time and successful completion of the clinical trial for our Stool Bacterial Pathogens Panel, which, if FDA clearance is obtained, will be the second multiplex panel we’ll be able to offer the market. This trial completion is representative of our continued strategy and commitment to developing and delivering molecular diagnostics solutions to help hospitals of all sizes combat the misdiagnosis and spread of infectious disease and improve their antimicrobial stewardship,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific.
Great Basin Scientific’s Stool Bacterial Pathogens Panel allows for simultaneous detection of key bacterial pathogens and the Company believes better supports customer needs, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times (96 hours). The Company’s multiplex assay allows for simultaneous detection of important bacterial pathogens, offers an easy-to-use workflow and a turnaround time of under two hours. The assay can quickly detect pathogens from a patient’s preserved stool sample with less than two minutes of few hands-on steps.
Great Basin Scientific initiated clinical trials for the Stool Bacterial Pathogens Panel in April 2016. Great Basin Scientific currently has four commercially available tests, the Staph ID/R Blood Culture Panel, Shiga Toxin Direct Test, tests for Group B Streptococcus (GBS), and toxigenic Clostridium difficile (C. diff). The Company also has four tests in development phase; Nasal S. aureus Pre-surgical Screen, Candida Blood Infections Panel, CT/NG Test, and the Bordetella Direct test.
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.
Forward-Looking Statements
This press release includes forward-looking statements regarding the Company’s continuing business efforts related to its products, including but not limited to statements regarding the Company’s intent to seek 510(k) clearance from the FDA for the Stool Bacterial Pathogens Panel and CE marking, the potential future marketing of the the Stool Bacterial Pathogens Panel if FDA clearance is obtained, the potential benefits of the the Stool Bacterial Pathogens Panel for the Company’s potential customers, planned tests to be brought to clinical trial in 2016, expansion of the Company’s menu, the Company’s development goals and other similar statements. 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; (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 fiscal year ended December 31, 2015 and Quarterly Report on From 10-Q for the quarter ended June 30, 2016. 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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