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FDA Grants Emergency Use Authorization for Michigan State University COVID-19 Molecular Assay

NEW YORK – The US Food and Drug Administration last week granted Emergency Use Authorization for Michigan State University laboratories' In-Dx SARS-CoV-2 RT-LAMP Assay for COVID-19 detection.

The laboratory-developed test uses nasopharyngeal swab specimens collected by healthcare providers to detect the SARS-CoV-2 virus in people with suspected COVID-19. The test can only be performed by the laboratories of the Michigan State University Department of Medicine Olin Student Health Center, which are CLIA certified to perform high-complexity tests.

The test uses reverse transcription loop-mediated isothermal amplification (RT-LAMP) for qualitative detection of the SARS-CoV-2 virus in samples collected with swabs and viral transport medium.

FDA officials said earlier this year that they have been winding down EUA reviews of new in vitro diagnostics. The agency said its authority to issue EUAs is separate from the public health emergency declaration that expired in May and that it would provide test developers 180 days' notice before the termination of the EUAs. It intends to exercise the same enforcement approach to COVID-19 LDTs as it does for other LDTs.