Shiga Toxin Direct Test diagnostic filed with FDA for Shiga toxin-producing E. coli- Great Basin Scientific

Great Basin Scientific 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.

The Shiga Toxin Direct Test offers 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 potentially providing cost savings. The Shiga Toxin Direct Test quickly detects Shiga toxin-producing E. coli – specifically stx1 and stx2 genes – in addition to identifying the serotype O157. E. coli O157 can lead to a life-threatening condition called haemolytic uremic syndrome (HUS), characterised by haemolytic anaemia and renal failure. By including identification of O157 in the test, a laboratory can avoid running additional tests or panels to get the definitive answers clinicians need for timely and accurate course of care, providing the means to avoid health complications that may result from misdiagnosis.