Great Basin Scientific Inc (NASDAQ:GBSN) a molecular diagnostics company, announced that its Shiga Toxin Direct Test is available for use outside of the U.S., having earned the CE marking designation under the European Directive on In VitroDiagnostic Medical Devices. The test is now qualified for distribution in more than 32 countries across Europe.
Great Basin’s Shiga Toxin Direct Test is the only standalone molecular test approved by the U.S. Food and Drug Administration (FDA), enabling the fast, precise detection of STEC, which are a leading cause of bacterial enteric infections in the U.S. according to the Center of Disease Control (CDC). The CDC has emphasized the importance of appropriate treatment early in the course of STEC infections. In Europe, the European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA) came together just last April to assess an outbreak of STEC, urging EU Member States to intensify their monitoring for the infection. Great Basin’s test aids a faster diagnosis and provides laboratory technicians with a streamlined workflow, enabling sample-to-result testing with less than one minute of hands-on time and no specimen enrichment step.
“At a time when outbreaks caused by dangerous bacterial infections like STEC dominate the news, the need for faster identification and detection of the culpable strains and genes to improve clinical outcomes for patients is greater than ever,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “We look forward to driving new site placements for the Shiga Toxin Direct Test now that we have secured CE Marking, and extending the benefits of our unique, direct-from-patient test to labs and patients beyond the U.S.”
The Shiga Toxin Direct Test is the third CE marked molecular diagnostic assay designation for Great Basin, following its tests for Group B Streptococcus (GBS) andClostridium difficile (C. diff). (Original Source)
Shares of Great Basin Scientific are currently trading at $1.68, up $0.05 or 3.07%. GBSN has a 1-year high of $6720 and a 1-year low of $1.60. The stock’s 50-day moving average is $2.02 and its 200-day moving average is $13.39.
Great Basin Scientific, Inc. is a molecular diagnostic testing company, which focused on the development and commercialization of its patented, molecular diagnostic platform designed to test for infectious disease, especially hospital-acquired infections.