Great Basin Scientific, Inc. have launched the Shiga Toxin Direct Test, the only stand-alone test to provide the CDC recommended identification of the high-virulence serotype O157 in conjunction with detecting Shiga toxin producing Escherichia coli, or STEC, giving clinicians definitive patient diagnosis to make timely decisions on the right course of treatment.

The Company reports it began evaluations at sites in July and reaffirms that it expects to attain 50 percent penetration of its installed customer base using the Shiga Toxin Direct Test within five to seven months. “We are very excited about the market response we’ve received for our Shiga Toxin Direct Test, both from our existing customer base and from brand new opportunities including larger reference laboratories,” said Ryan Ashton, co-founder and chief executive officer of Great Basin Scientific. “We’re further encouraged to discover test volume estimates are proving to be higher than we initially expected, much of which is a result of demand from larger sites for this unique and valuable assay.

Existing STEC detection methods vary from extremely expensive to time consuming and inaccurate. In contrast, Great Basin’s Shiga Toxin Direct Test is easy to use, competitively priced and provides more answers than other stand-alone tests. Further, by placing our analyzer at no cost, we remove the financial barriers previously seen in molecular diagnostics so hospitals and labs of all sizes can provide superior medical and economic value.”

STEC is a leading cause of infections like acute gastroenteritis and hemolytic-uremic syndrome, and the Centers for Disease Control and Prevention (CDC) has stressed the significance of early detection to manage STEC-related infections. Great Basin’s test simplifies the workflow for laboratory technicians, enabling sample-to-result testing with less than one minute of hands-on time using a patient’s preserved stool without overnight enrichment. Great Basin’s Shiga Toxin Direct Test is the only standalone molecular test detecting both Shiga toxin-producing E. coli and E. coli O157 cleared by the U.S. Food and Drug Administration (FDA).

The fully enclosed cartridge assay runs on the Great Basin Analyzer. "Rapid and accurate identification of STEC in symptomatic patients is essential for optimal disease management,” said Dr. Blake W. Buchan, Assistant Professor of Pathology and Associate Director of Clinical Microbiology at the Medical College of Wisconsin, a clinical trial site for Great Basin’s Shiga Toxin Direct Test. "Unlike other causes of acute gastroenteritis, administration of antibiotics may actually increase the risk of severe complications and is not recommended by the CDC.

An inexpensive, rapid molecular test can address the shortcomings of current culture and EIA methods by providing a result in as little as 2 hours without the need for broth enrichment of the stool and multiple additional diagnostic tests. The high sensitivity of molecular tests enables detection of STEC in more specimens, which means more patients get a definitive diagnosis and can be treated appropriately more quickly.” The Shiga Toxin Direct Test recently received the CE marking designation under the European Directive on In Vitro Diagnostic Medical Devices. It is the third CE marked molecular diagnostic assay designation for Great Basin, following its tests for Group B Streptococcus (GBS) and Clostridium difficile (C. diff).