Great Basin Scientific Receives FDA 510(k) Clearance for Bordetella Direct Test:
"SALT LAKE CITY, April 03, 2017 (GLOBE NEWSWIRE) -- Great Basin Scientific, Inc. (GBSN), a molecular diagnostics company, has received U.S. Food & Drug Administration (FDA) clearance for its Bordetella Direct Test, following a 510(k) submission on February 1, 2017. The Company received notification of clearance from the FDA on Friday, March 31, approximately 57 days from submission. The Bordetella Direct Test expands Great Basin’s menu of FDA cleared assays to five.
“More than a year ago, we created a clinical affairs team tasked with streamlining our clinical trial processes and strengthening our methods for presenting submissions to the FDA, with the objective of more rapidly and efficiently expanding our product menu,” said Robert D. Jenison, chief technology officer, Great Basin. “Pertussis is a very contagious disease and the incidence is steadily rising, so the swift response and clearance from the FDA is gratifying and substantiates that our investment in this aspect of our business has been well placed.”
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.
“We are pleased with the speed in which this test was cleared, and are further encouraged by the higher-than-expected demand from our customer base requesting immediate evaluations of Bordetella Direct,” said Ryan Ashton, co-founder and chief executive officer of Great Basin. “Children’s hospitals, in particular, are seeing a growing call for pertussis testing, while at the same time experiencing a reduction in reimbursements. Our on-demand test is fast, easy-to-use, and cost effective, making it a compelling option to meet growing demands.”
In addition to its Bordetella Direct test, Great Basin has 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.
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
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect future operating results and financial position, including but not limited to statements regarding market acceptance of and demand for the Company’s 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: changes in customer needs; competition in the industry being greater than anticipated; the Company’s limited operating history and history of losses; its ability to develop and commercialize new products and the timing of commercialization; its ability to obtain sufficient capital to continue as a going concern and implement our business plan; and other risks set forth in 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 specifically disclaims any obligation to update these forward-looking statements, except as required by law." |
