Great Basin Scientific, Inc. Submits 510(K) Application To FDA For Group B Strep Assay
SALT LAKE CITY, Nov. 19, 2014 /PRNewswire/ -- Great Basin Scientific, Inc., (NASDAQ: GBSN), a molecular diagnostics company, today announced it has submitted its Group B Strep assay to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. The submission of the Group B Strep assay comes after the successful completion of a clinical trial that met all the Company's objectives. The trial included 518 prospective samples at several hospital-based clinical laboratories in the United States. Great Basin anticipates commercial release of the Group B Strep assay in the second quarter of 2015, pending FDA clearance.
Group B Streptococcus, or GBS, continues to be a major perinatal pathogen, for both mothers and their infants, and is the leading cause of early-onset sepsis and meningitis in the United States. The Great Basin GBS sample-to-result assay is used to detect Streptococcus agalactiae (group B Streptococcus) from vaginal/rectal swabs collected from antepartum women at weeks 35-37 of pregnancy in an enriched LIM broth. The results aid physicians in determining if antibiotic treatment needs to be given to the pregnant woman to prevent the transmission of GBS to the child during delivery.
"With the Company's recent IPO, we now have the resources to move a significant number of projects from R&D into a final development and clinical trial phase, " said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin. "We believe our technology is unique in that allows us to deliver both low-plex assays and multi-plex panels, a capability that that we believe no other molecular diagnostics provider is currently able to offer but that is critical for meeting the needs of the microbiology lab. We look forward to expanding our menu beyond our current C. diff assay and thus be able to better serve more hospitals and reference labs with the product menu they need to quickly report accurate, definitive results."
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 the commercial release of the Group B Strep assay, the status of other low-plex assays and multiplex panels, and the expansion of our product menu. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
Media Contact:
Martina Schwarzkopf, Ph.D.
Russo Partners, LLC
212.845.4292
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Investor Relations Contact:
Bob Yedid
ICR
646.277.1250
Bob.Yedid@icrinc.com
SOURCE Great Basin Scientific, Inc.