The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), has awarded a research grant to Great Basin Scientific and Brigham Young University (BYU), to develop a rapid molecular diagnostic test direct from whole blood for carbapenem-resistant Enterobacteriaceae (CRE). The NIH research grant (R01AI116989) will play a key role in meeting the goals of President Obama’s recent National Action Plan for Combating Antibiotic-Resistant Bacteria. 

The BYU-Great Basin team will utilize Great Basin’s fully disposable cartridge system requiring minimal preparation, and patented chip-based detection method to develop a multiplexed nucleic acid-based high sensitivity assay for the detection and identification of multi-drug resistant Enterobacteriaceae from whole blood. 
According to the Centers for Disease Control (CDC), some CRE bacteria, generally found in hospitalized patients or residents in long-term care facilities, have become resistant to most available antibiotics. Infections with these germs are very difficult to treat, and can be deadly, as one report cites they can contribute to death in up to 50 percent of patients who become infected.

“One of the strengths of Great Basin’s molecular platform is our ability to detect direct from unpurified clinical specimen, a capability that was critical to our success in securing this grant from the NIH,” says Robert Jenison, senior vice president of research and development and chief technology officer of Great Basin. “By avoiding time-consuming sample purification and multiplex limitations of traditional polymerase chain reaction (PCR) tests, we are working towards offering better clinical outcomes for those infected with CRE and other deadly superbugs – especially critical given the rising incidence of CRE outbreaks like those we saw recently in California. We are thrilled about our collaboration with BYU and look forward to delivering this first of many direct-from-specimen tests on the Great Basin platform.”   

Per the NIH grant guidelines, the research team plans to demonstrate identification of bacteria in a whole blood specimen within one hour. The initial focus of the test will be to detect and characterize Enterobacteriaceae isolated directly from a blood sample. The researchers chose this specific bacterial target as bloodstream infections caused by carbapenem-resistant Enterobacteriaceae have become increasingly problematic in the U.S. The test method, without PCR amplification requirement, has a simplified workflow and greater multiplex capabilities, and the platform developed by the researchers will be readily expandable to additional pathogens and their relevant antibiotic-resistant genes. 

“Great Basin is delivering a rich suite of products that leverage our technology to provide low-plex, multiplex and now direct-from-specimen tests, like the one being developed with the NIH award,” says Great Basin co-founder and CEO Ryan Ashton. “In addition to this direct-from-specimen test for CRE, we are also in early stage development for a test that identifies Candida species direct from whole blood specimen, without the 24-hour culture step most molecular tests currently require. We are confident this broad platform of tests and panels will become powerful tools that help our hospital customers treat their patients more quickly and accurately, leading to better patient outcomes and lower healthcare costs.”