Company receives CE marking; customer evaluations have begun for first multiplex panel, delivering healthcare providers in U.S. and Europe a new resource for antimicrobial stewardship
Salt Lake City, September 20, 2016 – Great Basin Scientific, Inc. (Nasdaq:GBSN), a molecular diagnostics company, announced today the U.S. and European commercial launch of its Staph ID/R Blood Culture Panel, the Company’s first multiplex panel. This sample-to-result, automated panel benefits hospitals and laboratories by detecting, in about two hours, bloodstream infections caused by MRSA and other Staphylococcus species, enabling accurate, timely, and cost-effective diagnosis and treatment of patients. The panel detects the mecA gene, a major drug resistance marker that confers resistance to methicillin and other beta-lactams and creates the superbug MRSA. The assay is unique in its ability to distinguish Coagulase-negative Staphylococci (CoNS), which may not require treatment with antibiotics, from pathogenic Staphylococci, and can therefore assist healthcare organizations with antimicrobial stewardship programs and campaigns.
“The commercial launch of our Staph ID/R Blood Culture Panel marks a major milestone in our growth as a company as we deliver on our unique capability of providing low-plex, direct-from- specimen and multiplex testing on a single platform,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “Additionally, we’re pleased to be able to offer a significant tool for hospitals and labs as they implement antimicrobial stewardship programs into their broader healthcare strategy. The need for a solution to help clinicians battle antibiotic resistance is so great, nearly half of our installed customer base has already expressed an interest in our Staph ID/R Blood Culture Panel. Further, this panel is opening doors for our sales team at new larger sites not previously open to the Great Basin platform. Our Staph ID/R Blood Culture Panel will allow the clinical laboratory to play an important role in achieving the antimicrobial stewardship goals of improving patient care, reducing costs, and combating emerging antimicrobial resistance.”
The Centers for Disease Control (CDC) reports that between 20 and 50 percent of all positive blood cultures are likely false positives due to contamination caused by CoNS, which are not usually pathogenic. However, some species have been associated with a growing number of hospital-acquired infections as well as antibiotic resistance caused by overuse or incorrect dosing or duration of these drugs. By clearly identifying CoNS, the Great Basin Staph ID/R Blood Culture Panel equips healthcare providers with actionable data they can leverage to quickly determine appropriate treatment paths, while helping eliminate false positives and inaccurate information that can lead to antibiotic resistance and outbreaks at a broader level. Informing disease-appropriate treatment for patients and curbing the unnecessary use of broad- spectrum antibiotics directly supports the larger fight against antibiotic-resistant infections, while lowering patient treatment costs, reducing potential readmissions and extending those savings to a hospital’s bottom line.
Staph ID/R Blood Culture Panel has received CE marking designation under the European Directive on In Vitro Diagnostic Medical Devices, extending the availability to facilities across 32 countries in the EU and Great Britain. Great Basin Scientific currently has four commercially available assays, the Staph ID/R Blood Culture Panel, Shiga Toxin Direct Test, Group B Streptococcus (GBS) Test and Toxigenic Clostridium difficile (C. diff) Test. The Company has five additional tests and panels in development phase; Nasal S. aureus Pre-Screen, Candida Blood Infections Panel, Stool Bacterial Pathogens Panel, CT/NG Test and Bordetella Direct Test. All commercially available assays, as well as those in development run on the Great Basin analyzer.
The Company expects the Staph ID/R Blood Culture Panel to contribute meaningfully to revenue beginning in the second half of 2017, due to the panel’s longer customer evaluation period.
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 statement regarding events, trends and business prospects, which may affect our future operating results and financial position, including but not limited to statements regarding 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, the expected contribution of the Staph ID/R Blood Panel to Company revenue, 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 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 year ended December 31, 2015 and Quarterly Report on Form 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.