Shiga Toxin Direct Test Gets CE Mark

The Shiga toxin direct test from Great Basin Scientific Inc, Salt Lake City, has earned the CE mark designation under the European Union’s Directive on In Vitro Diagnostic Medical Devices. The test is now qualified for distribution in more than 32 countries across Europe.

The test enables the detection of Shiga toxin-producing E. coli (STEC), which the US Centers for Disease Control and Prevention (CDC) has identified as a leading cause of bacterial enteric infections in the United States. 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 and the European Food Safety Authority came together last April to assess an outbreak of STEC, urging EU member states to intensify their monitoring for the infection.

Great Basin’s test supports sample-to-result testing with less than 1 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,” says Ryan Ashton, cofounder 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 US.”

The Shiga toxin direct test is the third CE-marked molecular diagnostic assay designation for Great Basin, following its tests for Group B Streptococcusand Clostridium difficile.

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Reference: CLP Magazine