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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. 

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