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
SALT LAKE CITY, April 22, 2015 - 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.
- Published: 22 April 2015
- Written by Editor