The FDA has granted 510(k) clearance for the Shiga Toxin Direct Test from Great Basin Scientific, Inc., providing the only FDA-cleared stand-alone molecular test to detect Shiga toxin-producing E. coli (STEC) and the serotype O157 directly from a patient specimen. The Shiga Toxin Direct Test can be run on the Great Basin Analyzer, which also performs Great Basin’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS), as well as the Company’s multi-plex Staph ID/R Blood Culture Panel, which is pending 510(k) clearance from the FDA.

The CDC reports STEC are a leading cause of bacterial enteric infections in the United States and has issued patient testing guidelines to ensure as complete as possible detection and characterization of STEC and STEC O157 infections to help avoid serious complications for patients and improve clinical outcomes. 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. The conventional methods of testing for STEC, however, demonstrate low sensitivity (54.7 percent) compared to PCR¹ and take significant time and effort, requiring 36-120 hours to receive a result.

Great Basin’s Shiga Toxin Direct Test enables a streamlined workflow for laboratory technicians, offering sample-to-result testing with less than one minute of hands-on time, and without a specimen enrichment step. Quickly detecting stx1 and stx2 genes provides information clinicians need to make appropriate and timely therapeutic decisions to improve patient outcomes and the potential for lower overall cost of care. Great Basin’s Shiga Toxin Direct Test also identifies the serotype O157, a strain of E. coli linked to development of hemolytic uremic syndrome (HUS), a life-threatening condition.

“We are pleased to receive 501(k) clearance for our Shiga Toxin Direct Test, and are excited about the opportunity to drive new site placements with this unique test,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “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. The clearance of this test is particularly timely given the growing number of multistate outbreaks for Shiga toxin-producing Escherichia coli O157 (STEC O157) infections.”

Reference: 1 Real-Time PCR Assay for Detection and Differentiation of Shiga Toxin-Producing Escherichia coli from Clinical Samples. J Clin Microbiol. 2015 Jul;53(7):2148-53. doi: 10.1128/JCM.00115-15. Epub 2015 Apr 29.