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Journal of Clinical Microbiology Publishes Study Demonstrating Accuracy and Specificity of Great Basin Corporation's Staph ID/R Molecular Diagnostic Test

A study published in the March 2012 issue of the Journal of Clinical Microbiology demonstrates that Great Basin Corporation's Staph ID/R rapid, automated DNA multiplex assay can identify major pathogenic strains of Staphylococcus to the species level as well as the presence or absence of the methicillin-resistance determinant gene, mecA. In this study, the assay was 99 percent accurate in comparison to DNA sequencing results.

Staphylococcal infections are one of the leading causes of hospital acquired infections (HAI) worldwide, and up to 60 percent of all staphylococcal infections are methicillin resistant (MRSA). More than 2 million people are diagnosed with an HAI in the U.S. each year, causing approximately 90,000 deaths. Studies have shown that reducing the time to diagnose patients with staphylococcal infections decreases the length of stay at hospitals as well as the rates of morbidity and mortality.

"Great Basin is focused on developing low-cost technology that enables healthcare providers to diagnose patients faster, resulting in better patient outcomes and decreased costs associated with unnecessary tests," said Ryan Ashton, CEO and president, Great Basin Corporation. "The results of this study are particularly encouraging, especially since staphylococcal sepsis infections, such as MRSA, remain an important public health problem that still lack complete information at an appropriate cost."

Researchers from Great Basin Corporation, Denver Health Hospital and the Children's Memorial Hospital in Chicago assessed the sensitivity and specificity of the Staph ID/R test and determined that Staph ID/R has excellent specificity with no non-specific cross-reactivity observed.

"The use of Staph ID/R could positively affect patient management and laboratory workflow," said Robert Jenison, chief technology officer for Great Basin Corporation and lead author of the study. "A significant advantage of the Staph ID/R test is that it can provide species information that may significantly speed up the diagnosis process, ensuring patients get the right treatment sooner. Also, nearly one-third of all positive blood cultures are from contamination and this test can identify these cases to remove patients from costly and unnecessary therapeutic interventions."

Great Basin's highly sensitive, easy-to-use, integrated cartridge system allows for more accurate and information-rich detection of infectious diseases, allowing providers to diagnose and define a clear treatment path sooner for improved patient outcomes, shorter hospital stays and significant cost savings. The company's goal is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostic solutions.

Great Basin's technology entails an integrated disposable cartridge containing all necessary reagents and an inexpensive bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician. The platform has several key advantages over other molecular solutions:
  • Results in less than one hour, depending on the target of interest
  • True sample-to-result with no more than two to three hands-on steps
  • On-demand testing; no batching tests that delay results
  • Multiplexes up to 64 distinct targets in a single assay
In addition to Jenison, the study was authored by Brian Hicke, Chris Pasco, John Dunn, Heidi Jaeckel, Dan Nieuwlandt, and Evelyn Woodruff of Great Basin Corporation; Diane Weed of Denver Health Hospital; and Xiaotian Zheng of Children's Memorial Hospital in Chicago. In November 2011, the company submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its first molecular diagnostic test for Clostridium difficile (C. diff). The company intends to begin clinical trials for the Staph ID/R assay in 2012.

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