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# FDA Clears Great Basin Shiga Toxin Test
- URL: https://www.fdaweb.com/fda-clears-great-basin-shiga-toxin-test/
- Published: 2016-03-23T12:00:00.000Z
- Updated: 2026-09-14T20:50:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135171

> FDA has cleared a Great Basin Scientific 510(k) for its Shiga Toxin Direct Test, a stand-alone molecular diagnostic for detecting Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen. The test can be run on the Great Basin Analyzer, which also performs low-plex tests for Clostridium difficile and Group B Streptococcus.  
>  
> CDC reports STEC are a leading cause of bacterial enteric infections in the U.S. and has issued patient testing guidelines, according to the company. “Providing patients with appropriate treatment early in the course of STEC infections is especially critical as improper antibiotic therapy in patients with STEC infections may be associated with more severe disease, including renal damage or even death,” it says.