NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Anavasi Diagnostics' molecular point-of-care AscencioDx COVID-19 Test Kit.
The test, which the company submitted to the FDA for EUA about a year ago, uses reverse transcription loop-mediated isothermal amplification to detect SARS-CoV-2 nucleic acid in direct anterior nasal swab specimens. It runs on the company's AscencioDx Molecular Detector, a portable, multiplex testing device that yields results in around 30 minutes, according to Seattle-based Anavasi.
Use of the test is limited to labs CLIA-certified to perform high-, moderate-, or waived-complexity tests, the FDA said. It is also authorized for use at the point of care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.