Skip to main content
Premium Trial:

Request an Annual Quote

Great Basin STEC Test Garners CE Mark

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.

The Scan

Suicidal Ideation-Linked Loci Identified Using Million Veteran Program Data

Researchers in PLOS Genetics identify risk variants within and across ancestry groups with a genome-wide association study involving veterans with or without a history of suicidal ideation.

Algorithm Teases Out Genetic Ancestry in Individuals at Biobank Scale

Researchers develop an algorithm known as Rye to tease apart ancestry fractions in admixed individuals at a biobank-scale, applying it to 488,221 UK Biobank participants in Nucleic Acids Research.

Multi-Ancestry Analysis Highlights Comparable Common Variants at Complex Trait-Linked Loci

Researchers in Nature Genetics examine common variants implicated in more than three dozen conditions, estimating genetic effect similarities across ancestry tracts in admixed individuals.

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.