Shiga Toxin Direct Test Receives FDA Clearance

The conventional methods of testing for STEC, however, demonstrate low sensitivity of 54.7% compared to polymerase chain reaction (PCR) and take significant time and effort, requiring 36 hours to 120 hours to receive a result.

The US Food and Drug Administration (FDA; Silver Springs, MD, USA) have granted 510(k) clearance for a Shiga Toxin Direct Test. The test is 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 (Great Basin Scientific, Inc.; West Valley City, UT, USA) 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.

The test quickly detects shiga-like toxin (stx1) and stx2 genes providing 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. 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 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.

Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific, said, “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 infections.”

Related Links:
US Food and Drug Administration 
Great Basin Scientific