Great Basin Submits to FDA for Group B Strep Assay
Great Basin Scientific, Inc., has submitted its Group B Strep assay to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Combining isothermal amplification with chip-based detection in a sample-in/result out format Great Basin Scientific have created a molecular diagnostics platform with distinct advantages over current technologies.
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.
“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, cofounder 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.”
Tags: Clostridium difficile, Group B Streptococcus
Date Published: November 24, 2014
Source article link: Great Basin Corp. » company contact details
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