NEW YORK – Minute Molecular Diagnostics announced on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its DASH SARS-CoV-2/S molecular test.
The RT-PCR test returns results in approximately 15 minutes from an anterior nasal swab and runs on the firm's DASH Analyzer, which consolidates the sample extraction, amplification, and thermocycling processes. The point-of-care platform is portable and can be operated by untrained users, the company said in a statement.
The Evanston, Illinois-based company is beginning production of the test and seeking both government and private partnerships to "accelerate the delivery" of the test and its analyzer, it added.
Development of the test, which is authorized for use in CLIA-certified labs and CLIA-waived settings, was partially funded by the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative and NIH's National Institute of Biomedical Imaging and Bioengineering. The firm received $21.3 million from RADx in April 2021 to develop the test and analyzer.
Minute Molecular was founded in 2017 as part of Northwestern University's Center for Innovation in Global Health Technology. The DASH platform could also be adapted to other infectious viral and bacterial agents and sample types, the firm said.