SALT LAKE CITY, Dec. 10, 2014 /PRNewswire/ -- Great Basin Scientific, Inc. (NASDAQ: GBSN), a molecular diagnostics company, today announced it has initiated a clinical trial for its sample-to-result Staph ID/R (identification/resistance) diagnostic test. This is the second clinical trial the Company has initiated since July 2014 and, upon submission and if granted 510(k) clearance by the U.S. Food and Drug Administration (FDA), Staph ID/R will be Great Basin’s third molecular diagnostic assay. In November of this year, the Company submitted its Group B Strep assay to FDA for 510(k) clearance. In 2012 the Company launched its FDA-cleared Toxigenic C. diff assay.
Further, the Company announced that it has added two additional tests, a fungal panel and a test for Shiga toxin-producing E. coli (STEC) infections, to its clinical trial roadmap for 2015.
“Great Basin continues to make effective use of the funds raised in our recent IPO, which have allowed us to initiate the clinical trial for Staph ID/R several months ahead of schedule,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin. “Further, better-than-expected progress in R&D has expedited our ability to move products into clinical trials sooner than anticipated. Great Basin’s technology uniquely allows us to provide both low-cost, low-plex tests and high-value, multi-plex panels, a real competitive advantage. Staph ID/R will be the first of many multi-plex panels we intend to bring to market which, we believe, offer significant cost advantages and ease-of-implementation and will provide improved patient care for the small-to-medium hospitals we serve.”
Compared to competitive molecular assays for blood-borne staph infections, the Great Basin Staph ID/R assay will offer speciation of several clinically critical staphylococcus species. Speciation of individual Staphylococcus species allows clinicians to accurately and promptly distinguish environmental contaminants (which comprise 20-30% of total positive blood cultures) from truly infectious pathogens, further directing appropriate treatment and reducing unnecessary treatment costs. The Company believes this important information will provide a significant benefit in therapeutic decision-making for the administration of effective treatments. Further, the sample-to-result assay will require less than two minutes hands-on time and will provide a result in less than two hours, supporting timely diagnosis, which can reduce mortality rates, the duration of hospital stays and overall costs due to sepsis.
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
Certain statements in this press release may be deemed to be forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the commercial release of the Group B Strep assay, the status of other low-plex assays and multiplex panels, and the expansion of our product menu. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history or 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
Media Contact:
Martina Schwarzkopf, Ph.D.
Russo Partners, LLC
212.845.4292
martina.schwarzkopf@russopartnersllc.com
Investor Relations Contact:
Bob Yedid
ICR
646.277.1250
bob.yedid@icrinc.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/great-basin-initiates-clinical-trial-for-staph-idr-molecular-diagnostic-test-300008094.html
SOURCE Great Basin Scientific, Inc.
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