Study Published in Journal of Clinical Microbiology Reports the Sensitivity and Specificity of Great Basin Corporation’s Molecular Diagnostic Test
Great Basin CorporationSandra Nielsen, 801-990-1055orEdelmanJennifer Chan, 415-229-7650
A study published in the August issue of showed that Great Basin Corporation’s toxigenic () molecular diagnostic test has a 97 percent sensitivity and 100 percent specificity rate compared with a competing FDA-approved polymerase chain reaction (PCR) test. In May, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Great Basin’s assay.
According to the Centers for Disease Control and Prevention, the rate of infection for remains at historically high levels and the severity of the disease in the U.S. has risen alarmingly, resulting in an estimated $1 billion annually in additional heath care costs. Because of the growing challenges of the disease, is one of the infections targeted in the U.S. Department of Health and Human Services, which is a federal initiative to reduce preventable infections in hospitals.
“The need for early and accurate diagnosis of has never been more critical in both assuring a positive outcome for the infected patient and in preventing the spread of to other at-risk patients,” said Rob Jenison, Great Basin CTO and study co-author. “Results of this study were similar to our recently completed clinical trial, demonstrating the sensitivity and specificity of Great Basin’sassay. By addressing the growing need for accurate and quick testing, we provide a significant advantage to hospitals in reducing the rate and recurrence of this life-threatening infection.”
In addition to FDA clearance, the assay has received CE-IVD product marking, allowing the test to be marketed in both the U.S. and the EU.
“Since we began marketing our assay in May, the reception from clinicians has been enthusiastic, thanks to our unique ability to offer accurate results coupled with a simplified workflow and competitive pricing,” said Ryan Ashton, president and CEO, Great Basin Corporation. “We are encouraged by the data regarding the sensitivity and specificity of our breakthrough approach, and are eager to expand our menu of sample-to-result assays for other troubling infectious diseases such as staph, fungal infections,and tuberculosis.”
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:
The lead author of the study is Brian Hicke, director of research for Great Basin. In addition to Hicke and Jenison, co-authors from Great Basin include Chris Pasko, Benjamin Groves, Maylene Corpuz, Georges Frech, Denton Munns, Wendy Smith, Ashley Warcup, Wes Lindsey, Charles Owen, and Larry Rea. Additional co-authors are Edward Ager of the Clinical Microbiology-Immunology Laboratories at the University of North Carolina; Gerald Denys of Indiana University Hospital; and Nathan A. Ledeboer of the Medical College of Wisconsin’s Department of Pathology.
Great Basin Corporation is a privately held molecular diagnostics company that commercializes breakthrough chip-based technologies. The company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. By providing more diagnostic data per sample, healthcare providers are able to treat patients with the right medication sooner, improving outcomes and reducing costs. The company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at .