Company also has more than 40 sites in the U.S. currently evaluating or committed to evaluate under Investigational Use Only (IUO) labeling
Salt Lake City, April 12, 2017 – Great Basin Scientific, Inc. (OTCQB: GBSND) (the “Company”), a molecular diagnostics company, announced today it has received CE Marking for its Stool Bacterial Pathogens Panel. This is the Company’s fifth assay and second multiplex panel to receive CE Marking designation under the European Directive on In Vitro Diagnostic Medical Devices, which extends the availability of the Company’s panels to facilities across 32 countries in the European Union and Great Britain. The Company previously announced 510(k) submission to the U.S. Food and Drug Administration (FDA) of the Stool Bacterial Pathogens Panel on December 19, 2016 and is awaiting clearance to sell the panel domestically.
“We are pleased with our progress in commercializing this panel, and are excited to be able to offer it in Great Britain and the EU,” said Sandra Nielsen, senior vice president of sales and marketing of Great Basin Scientific. “We are especially encouraged by the interest from our U.S. customers, many of whom have chosen to evaluate the product under IUO labeling which will facilitate the completion of their required evaluation and validation process in advance of our expected FDA clearance. This early validation will allow sites to begin using the panel for live patient testing as soon as we receive expected FDA clearance and will accelerate their timeline for providing better patient diagnosis. We believe this unusual step many of our customers have taken is a testament to our ‘just-right’ sized approach to building syndromic panels.”
The Company’s Stool Bacterial Pathogens Panel is designed to simultaneously detect Salmonella species, Shigella species, Shiga Toxin-producing E. coli (stx1, stx 2, O157 serotype-specific genes), and Campylobacter species (C. jejuni and C. coli), key bacterial pathogens the Company believes better supports customer needs with an easy-to-use workflow of less than two minutes hands-on steps, and a turnaround time of under two hours, compared to conventional tests that are labor intensive, requiring multiple individual tests with poor sensitivity and long turnaround times (96 hours).
“Along with our Staph ID/R panel, this high-value panel is a powerful component of our product strategy designed to both meet the considerable testing and reimbursement challenges facing healthcare while delivering significantly higher gross margins to the Company than our low-plex tests,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “The value our customers have indicated they see from this product is driving early IUO validations which will speed adoption and potentially lead to faster growth in revenues for this new panel. We believe this product will become a major contributor to revenues in the second half of 2017 and into 2018, resulting in improved financial performance for the Company.”
Great Basin Scientific’s molecular diagnostics system offers low-plex and multiplex 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 a Staph ID/R Blood Culture Panel (SIDR) for identifying bloodstream infections caused by MRSA and other Staphylococcus species. Additionally, the Company announced last week that it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Bordetella Direct Test, which will be commercially launched later this month. 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 is awaiting FDA clearance on a Stool Bacterial Pathogens Panel, and has other tests in development, including a direct-from-blood Candida Blood Infections Panel, CT/NG Test, and a Nasal S. aureus Pre-surgical Screen 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.
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 market’s acceptance of the Company’s Stool Bacterial Pathogens Panel in the European Union and Great Britain, the Company’s commercialization plan regarding its Stool Bacterial Pathogens Panel, 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, 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