The U.S. Food and Drug Administration (FDA) recently gave the clearance for Great Basin Scientific Inc. to conduct its Shiga Toxin Direct Test.
The FDA gave them 510(k) clearance for the test, which is intended as a molecular test to detect E.coli that produces Shiga toxins. The test will most likely be tested on the Great Basin Analyzer, which also performs tests for Clostridium difficile and Group B Streptococcus.
The Great Basin Shiga Toxin Direct Test will allow lab techs to get immediate results from samples. It will require under one minute of hands-on contact. It will detect stx1 and stx2, while providing results quickly
“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,” Ryan Ashton, co-founder and CEO 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 multi-state outbreaks for Shiga toxin-producing Escherichia coli O157 (STEC O157) infections.”