Shiga Toxin Direct Test Submitted to FDA
Great Basin Scientific, Inc. has submitted its Shiga Toxin Direct Test to the FDA for 510(k) clearance following the successful completion of a clinical trial that met all of Great Basin’s clinical objectives. Upon clearance, the test will be the only stand-alone molecular test to detect Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen.
Believed by Great Basin to be superior to alternative tests on the market, the Company’s Shiga Toxin Direct Test offers true sample-to-result testing with less than three minutes of hands-on time, no specimen enrichment step, and presents much higher sensitivity than either non-molecular or antigen-based rapid tests, thereby simplifying workflow for laboratory technicians and providing cost savings while facilitating better patient care.
The Shiga Toxin Direct Test quickly detects Shiga toxin producing E. coli – specifically stx1 and stx2 genes – in addition to identifying the serotype O157.
Once approved and commercially available, the Shiga Toxin Direct Test can be run on the same Great Basin analyzer used to perform Great Basin’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS), and their multi-plex Staph ID/R Blood Culture panel currently in review by the FDA.
Tags: Escherichia coli inc STECs, Escherichia coli, Escherichia coli O157
Date Published: October 20, 2015
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