Great Basin Receives FDA 510(k) Clearance for Group B Strep Molecular Diagnostic Test
Menu expansion on track with first of three new molecular assays planned for this year
Apr 22, 2015, 08:00 ET
SALT LAKE CITY, April 22, 2015 /PRNewswire/ -- Great Basin Scientific, Inc. (NASDAQ: GBSN and GBSNU), a molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its molecular diagnostic test for Group B Streptococcus (GBS). This is Great Basin's second assay to be cleared by the FDA. The Company's first test, for Clostridium difficile, or C. diff, was approved in May 2012. Great Basin plans to launch the GBS assay commercially in the second quarter of 2015.
"Receiving FDA clearance for our GBS test represents a significant milestone for Great Basin, both as an expansion of our menu and as evidence of the company's ability to meet product deliverables," said Great Basin co-founder and Chief Executive Officer Ryan Ashton. "We are committed to delivering to hospitals and reference labs the products they need to quickly report accurate, definitive results, thus we are pleased with the on-time delivery of this test clearance. We look forward to growing our menu of tests over the next 18 months to further meet the need for easy-to-use and cost-effective molecular diagnostic testing."
According to the Centers for Disease Control (CDC), GBS disease remains the leading infectious cause of morbidity and mortality among newborns in the United States. Infants infected with GBS may have sepsis and pneumonia; additionally, early-onset infections can lead to meningitis. For infected infants, there may be long-term consequences such as deafness and developmental disabilities. The fatality rate of early-onset GBS disease is four to six percent.
Approximately 10 to 30 percent of all pregnant women are colonized with GBS in the genitourinary tract, which can be transferred to the infant during labor and delivery. GBS-colonized mothers are often asymptomatic and therefore the CDC recommends pregnant women get screened for GBS at 35 to 37 weeks of gestation. According to the CDC, there are nearly 4 million live births every year in the United States.
The Great Basin GBS assay provides accurate results in approximately 90 minutes with a specimen from enriched LIM broth. By targeting a highly conserved region of the cfb (CAMP factor) gene, the molecular assay provides definitive identification and a more rapid diagnosis of the mother's GBS colonization status compared to standard culture-based testing, which may take up to an additional 48 hours. These test results provide the physician with important information for making appropriate, timely therapeutic decisions to prevent the spread of this disease to the infant during delivery.
Great Basin's easy-to-use integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, capable of both low-plex and multi-plex targets, and allows providers to diagnose and define a clear treatment path sooner for improved patient outcomes, shorter hospital stays and significant cost savings. The Company's goal is to deliver assays that can be performed at a lower cost than other molecular diagnostic solutions.
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 our plans to launch the GBS assay commercially, the benefits of our products, the importance of this milestone, and the expected growth in the number of tests over the next 18 months. 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 Annual Report on Form 10-K for the year-ended December 31, 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.
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SOURCE Great Basin Scientific