Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic
FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.
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After federal agencies invested almost $500m to ensure Cue Health could scale up production, FDA announces the self-administered test will be available OTC. It's the agency's first emergency use authorization for an at-home molecular diagnostic test available nonprescription.