Great Basin Receives FDA 510(k) Clearance for Group B Strep Molecular Diagnostic Test

Great Basin Scientific, Inc. GBSN, 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