NEW YORK (GenomeWeb) – Great Basin Scientific said today that its Shiga Toxin Direct Test has garnered CE IVD marking, qualifying it for distribution in more than 32 countries across Europe.
The assay, which was approved by the US Food and Drug Administration in March, uses PCR to detect Shiga toxin-producing Escherichia coli (STEC) and serotype O157 directly from patient specimens. Specifically, the assay detects the stx1 and stx2 genes.
"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," Ryan Ashton, CEO and Cofounder of Great Basin, said in a statement. "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 molecular diagnostic assay from Great Basin to receive CE marking, following its tests for Group B Streptococcus and Clostridium difficile.
All of these tests run on the sample-to-answer, cartridge-based Great Basin Analyzer. The company unveiled a next-generation version of this platform, called the GB550, last week.