Study validates that Great Basin’s assay provides cost effective, rapid and definitive detection of Shiga Toxin-producing E.coli
Salt Lake City, February 3, 2017 – Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics company, today announced the Journal of Clinical Microbiology published results of a study analyzing the sensitivity and cost effectiveness of the Great Basin Shiga Toxin Direct Test in detecting Shiga Toxin-producing Escherichia coli (STEC) from stool specimens. The results of the study demonstrate an advancement in STEC detection, concluding that the molecular assay from Great Basin provides clinicians with a more cost-effective, rapid and definitive patient diagnosis, when compared to culture and EIA methods, enabling physicians to make more timely decisions on the appropriate course of treatment.
“Reducing the cost and labor associated with testing stool culture specimens—generally one of the most expensive and labor intensive tests for hospitals and labs—is providing significant value to our hospital administrator and lab director customers,” said Rob Jenison, chief technology officer and senior vice president of R&D at Great Basin Scientific. “The study also determined that the superior sensitivity and more rapid turnaround time, when compared to routine culture methods, aids in infection control efforts and identification of potential outbreaks 24 to 72 hours sooner.”
Led by Dr. Blake W. Buchan from the Department of Pathology at The Medical College of Wisconsin, MI, the study found that Great Basin’s Shiga Toxin Direct Test was 93.2 percent sensitive and 99.3 percent specific for detection of stx1 and stx2, and 95.7 percent sensitive and 99.3 percent specific for detection of E.coli serotype O157. Based on the data from this analysis, culture and EIA-based methods for detection of STEC are only 33 percent sensitive when compared to molecular tests. The total time to result for Great Basin’s Shiga Toxin Direct Test is approximately two hours, compared to approximately 36 to 48 hours for culture-based methods. Great Basin’s Shiga Toxin Direct Test is priced relative to common culture and Enzyme Immunoassay tests, at $24 per test, and provides a cost savings from routine stool culture when accounting for the total material and labor involved. Furthermore, the study concluded that Great Basin’s Shiga Toxin Direct Test increases the positive identification of Shiga Toxin-producing E.coli by three to four times, when compared to similar test panels.
The Great Basin Shiga Toxin Direct Test is the only stand-alone test to meet the Center for Disease Control’s recommendations for the identification of high-virulence serotype O157 in conjunction with detection of STEC. The Company announced the commercial launch of the Shiga Toxin Direct Test in August 2016, and the test also has CE mark designation under the European Directive of In Vitro Diagnostic Medical Devices.
Great Basin Scientific’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 STEC, Group B Streptococcus (GBS), Toxigenic Clostridium difficile (C. diff), and a Staph Blood Culture Panel for identifying bloodstream infections caused by MRSA and other Staphylococcus species. Continuing the Company’s efforts to expand its menu of sample-to-result assays to diagnose infectious disease, Great Basin Scientific 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 Company’s anticipated revenue growth, 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: the assumptions of management in the revenue projections not occurring as anticipated, 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.
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Reference: Journal of Clinical Microbiology