The firm said it is the only stand-alone test to provide the Center for Disease Control’s (CDC) recommended identification of the high-virulence serotype O157 in conjunction with detecting Shiga toxin-producing E. coli (STEC).
It began evaluations at sites in July and expects 50% penetration of its installed customer base using the test within five to seven months.
The test uses polymerase chain reaction (PCR) to detect the genes that encode the toxins (stx1 and stx2) in addition to an O157 specific antigen marker.
Ryan Ashton, co-founder and CEO of Great Basin Scientific, was positive about the market response from existing customers and new opportunities including larger reference laboratories.
“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.
“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.”
Great Basin said its test simplifies 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. The enclosed cartridge assay runs on the Great Basin Analyzer.
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 the test, said antibiotics may 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 two 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 test has CE marking designation under the European Directive on In Vitro Diagnostic Medical Devices.