Multicenter evaluation demonstrates Staph ID/R Blood Culture Panel’s efficacy in rapid identification of Staphylococci and detection of mecA gene
Salt Lake City, February 15, 2017 – Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, today announced the Journal of Clinical Microbiology published results of a multicenter study that demonstrated the effectiveness of its Staph ID/R Blood Culture Panel in rapidly identifying several species of Staphylococci and in accurately detecting the mecA gene directly from a positive blood culture. The results of the study, which was conducted across three clinical sites, demonstrated the performance and efficacy of the Staph ID/R Blood Culture Panel compared to conventional methods, and concluded that the Company’s panel provided decreased time to results at a lower price, helping physicians diagnose and deliver a timely, accurate and cost-effective course of treatment.
“Bloodstream infection-related sepsis, including those caused by MRSA and other pathogenic Staphylococcus species, is not only a leading cause of morbidity and mortality in the U.S., but is also associated with over $17 billion in rising healthcare costs annually. Traditional blood culture methods provide physicians with a diagnosis 48 to 72 hours after a positive sample is identified, delaying appropriate treatment and putting the patient at further risk,” said Rob Jenison, chief technology officer and senior vice president of R&D at Great Basin Scientific. “Great Basin’s Staph ID/R Blood Culture Panel is proven to provide highly accurate and actionable results in under two hours. Our panel potentially eliminates 32 to 88 hours of inappropriate antibiotic therapy, thereby potentially reducing length of patient stay and improving patient care – creating time and cost efficiencies for hospitals and labs of all sizes.”
Led by Dr. Gerald A. Denys from the Department of Pathology & Laboratory Medicine at Indiana University, the study found that Great Basin’s Staph ID/R Blood Culture Panel correctly identified positive results for Staphylococcus species 99.4 percent of the time and negative results were correctly identified 99.9 percent of the time. Also, the mecA gene, a major drug resistance marker conferring resistance to methicillin and other beta-lactams and creating the superbug MRSA, was detected accurately from positive samples 99.7 percent of the time and negative results were properly identified 99.2 percent of the time. The results of this study also revealed that the Great Basin molecular assay was more effective than conventional biochemical and cefoxitin disk methods performed at an independent laboratory, with performance estimates at 95 percent confidence intervals (CI) across all three sites. The Company believes the Staph ID/R Blood Culture Panel is one of the most comprehensive Staphylococcus molecular tests currently on the market, in that it identifies Staphylococcus aureus, Staphylococcus lugdunensis and other Staphylococcus species to the genus level and detects the mecA gene in all Staphylococcal species from positive blood cultures.
“We’re so pleased by the positive findings of this study and are excited by the response from the market for our blood culture panel,” said Sandra Nielsen, senior vice president, sales, marketing and HR at Great Basin. “The results of this study illustrate our panel’s accuracy, cost-effectiveness and ability to deliver definitive and highly actionable information which we believe contribute to the increased adoption of our panel by a significant percentage of our installed customer base, as well as new and larger hospitals and labs.”
The Company announced the commercial launch of the Staph ID/R Blood Culture Panel in U.S. and Europe in September 2016, and the test also has CE mark designation under the European Directive of In Vitro Diagnostic Medical Devices.
Great Basin’s molecular diagnostics system offers low-plex (one to three analytes), mid-plex (four to six analytes) and multiplex (syndromic) testing, with commercial assays available for the detection of Shiga Toxin-producing Escherichia coli (STEC), Group B Streptococcus (GBS), Toxigenic Clostridium difficile (C. diff), and Staph ID/R Blood Culture Panel. Continuing the Company’s efforts to expand its menu of sample-to-result assays to diagnose infectious disease, Great Basin has five additional tests on their product roadmap, including a Stool Bacterial Pathogens Panel and a Bordetella Direct Test, both of which recently completed clinical trials and have been submitted to the U.S. Food & Drug Administration (FDA) for 510(k) clearance; and a Nasal S. aureus Pre-surgical Screen, Candida Blood Infections Panel, and CT/NG Test, which are currently in development.
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.flywheelsites.com.
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding the anticipated current customer uptake of the Staph ID/R Blood Culture Panel, the effectiveness and role of the Staph ID/R Blood Culture Panel in patient care decisions, anticipated FDA approval of current pending assays, commercialization of future approved assays, and the Company’s general development plans of sample-to-result technology and products. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results, should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: delay or denial in obtaining FDA approval of pending assays, uncertainty in the Company’s ability to commercialize new assays, changes in customer needs, competition in the industry being greater than anticipated, our limited operating history and history of losses; our ability to develop and commercialize new products and the timing of commercialization; our ability to obtain sufficient capital to continue as a going concern and implement our business plan; and 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, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 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.View Post View/Download PDF
Reference: Journal of Clinical Microbiology