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Great Basin, BYU Using $5M NIH Grant to Develop Rapid CRE MDx

NEW YORK (GenomeWeb) – Great Basin Scientific and Brigham Young University said today that they are using a five-year, approximately $5 million grant from the National Institutes of Health to develop a rapid molecular diagnostic test to detect carbapenem-resistant Enterobacteriaceae (CRE) in whole blood.

Under the grant, administered by the National Institute of Allergy and Infectious Diseases, the researchers led by principal investigator and BYU research Aaron Hawkins will use Great Basin's disposable, automated cartridge system and chip-based detection method to develop the multiplexed nucleic acid-based assay, which will be able to identify bacteria in a whole blood specimen within one hour.

The researchers chose this specific bacterial target because bloodstream infections caused by CRE have become increasingly problematic in the US. According to the US Centers for Disease Control, 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.

The new test method does not require PCR amplification, has a simplified workflow and high multiplexing capabilities, and will be readily expandable to additional pathogens and their relevant antibiotic-resistant genes, Great Basin noted. For instance, the company is in the early stages of developing a test that identifies Candida species directly from whole blood without the 24-hour culture step required by most molecular methods.

"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," Robert Jenison, senior vice president of R&D and chief technology officer at Great Basin, said in a statement. "By avoiding time-consuming sample purification and multiplex limitations of traditional [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."

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