Upon FDA clearance, Company’s sample-to-result test will offer cost effective and easy-to-use testing for Bordetella pertussis or whooping cough
Salt Lake City, February 1, 2017 – Great Basin Scientific, Inc. (OTCQB: GBSN), a molecular diagnostics company, today announced the completion of the clinical trial and 510(k) submission to the Food and Drug Administration (FDA) of its Bordetella Direct Test. The Company’s sample-to-result test detects Bordetella pertussis directly from the patient specimen, identifying the bacterium behind the highly-contagious respiratory disease commonly known as whooping cough. The Company is also seeking a CE mark for this test.
“This submission of our Bordetella Direct Test to the FDA is exciting progress toward our goal of delivering an ever-growing menu of tests and panels that add value to the microbiology lab, which increases the attractiveness of our system to labs and hospitals and grows our potential revenue per customer,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “Furthermore, with the completion of the clinical trials and FDA submissions of our Bordetella Direct Test and Stool Bacterial Pathogens Panel, we expect a material reduction in research and development expenses starting in the current quarter.”
Pertussis in the U.S.
The Centers for Disease Control and Prevention (CDC), estimates that globally there are approximately 16 million cases of pertussis per year, with the disease being responsible for 195,000 deaths annually. Reported cases of pertussis in the U.S. have spiked since 1955, likely a result of declines in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, and continued circulation of B. pertussis in the population. Given the gravity of the disease as well as its capacity for contagion, hospitals, health systems and patients can benefit from the rapid detection and timely treatment of pertussis. Great Basin’s Bordetella Direct Test utilizes PCR, with media from nasopharyngeal swab specimens pipetted directly into a fully-enclosed assay cartridge, simplifying the workflow for laboratory technicians and enabling sample-to-result testing with less than one minute of hands-on time. The Bordetella Direct Test runs on the Great Basin Analyzer.
“Pertussis is a very contagious disease and the incidence is steadily rising,” said Sandra Nielsen, senior vice president, sales, marketing and HR. “We look forward to serving our customers with a valuable and cost-effective tool that provides faster and more accurate results over culture-based tests for life-threatening and life-changing diseases, like pertussis.”
The Bordetella Direct Test is an example of the Company’s commitment to developing simple-to-use, reliable and cost-effective molecular diagnostic solutions that produce timely results and help reduce the use of unnecessary and empirical antibiotic treatment. Great Basin also recently announced the 510(k) submission of its Stool Bacterial Pathogens Panel. Following expected FDA clearance of both the Stool Bacterial Pathogens Panel and Bordetella Direct Test, the Company will have six commercial assays on the market, with three additional assays 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.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.
Investor Relations Contact:
Great Basin Scientific
###View Post View/Download PDF