NEW YORK (GenomeWeb) – Great Basin Scientific today announced it has submitted its Shiga Toxin Direct Test to the US Food and Drug Administration for 510(k) review.
The submission follows the successful completion of a clinical trial by the Salt Lake City-based firm that met all of its clinical objectives, Great Basin said. If cleared, the test will be the only stand-alone molecular test for detecting Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen, it added.
The stool-based assay offers sample-to-result testing with less than three minutes of hands-on time, the company said, adding that the test requires no enrichment step but has a simple workflow that provides cost savings.
If approved, the test could be run on Great Basin's analyzer used to run the firm's Clostridium difficile and Group B Streptococcus assays, as well as the multiple Staph ID/R Blood Culture panel currently being reviewed by the FDA, the firm said.
"We are aggressively driving the development and commercialization of assays that provide small- to medium-sized hospitals and labs with the easiest to use and most cost-effective molecular diagnostic platform available," Great Basin Co-founder and CEO Ryan Ashton said in a statement. The Shiga Toxin Direct Test "is representative of our dedication to meet the market's demand for simpler methods and a better overall solution to infectious disease diagnostics," he added.