The National Institutes of Health (NIH) has awarded $14.9 million to Anavasi Diagnostics to accelerate the launch of the company’s molecular diagnostic platform that detects RNA indicative of the SARS-CoV-2 virus.
The company’s test, AscencioDx, uses LAMP (loop-mediated isothermal amplification) molecular diagnostic chemistry and hardware technology first developed at the University of Washington to detect HIV viral variants.
Anavasi said it expects to file its submission to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) for the AscencioDx soon. The initial EUA submission will claim effectiveness for administration by a licensed medical professional in a point-of-care setting, including physician offices, hospital emergency rooms, urgent care clinics, mobile testing sites, colleges and universities, as well as workspaces and other sites deemed appropriate by the healthcare professionals involved.
Nelson Patterson, CEO of Anavasi Diagnostics, said the test “can provide results in approximately 30 minutes comparable to lab-based polymerase chain reaction (PCR) tests. In addition, the AscencioDx platform almost completely eliminates false positives and negatives so frontline health workers no longer need to order multiple tests to ensure an absolute diagnosis. It's a one and done process that's like having a PCR lab in the palm of your hand."
The company also said the test has potential for at-home use pending further clinical validation and FDA clearance.