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Great Basin STEC Test Gets FDA 510(k) Clearance

NEW YORK (GenomeWeb) – Great Basin Scientific said today that its Shiga Toxin Direct Test has received 510(k) clearance from the US Food and Drug Administration.

The PCR-based test is designed to detect Shiga toxin-producing Escherichia coli (STEC) and serotype O157 directly from patient specimens. Specifically, the assay detects the stx1 and stx2 genes.

The assay runs on the Great Basin Analyzer, which offers sample-to-answer testing with less than one minute of hands-on time and without a specimen enrichment step. The platform also performs the company's commercially available tests for Clostridium difficile and Group B Streptococcus, and will run the firm's multiplex Staph ID/R Blood Culture Panel, which is pending FDA 510(k) clearance.

"By offering the only direct-from-patient specimen test, and identifying the O157 strain and quickly detecting stx1 and stx2 genes, we are providing clinicians a powerful tool to provide a better outcome for their patients," Great Basin Co-founder and CEO Ryan Ashton said in a statement. "The clearance of this test is particularly timely given the growing number of multistate outbreaks for [STEC O157] infections."

Earlier this month Great Basin reported a 37 percent year-over-year increase in fourth quarter revenues due to the initial adoption of its Group B Strep test, but reported a net loss of $18.9 million compared to a net income of $1.5 million in the same quarter last year.

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