ROI For US With FDA's Emergency Use Approval Of Cue Health's OTC At-Home COVID-19 Test
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.
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FDA published a supplemental template for molecular and antigen COVID-19 EUA sponsors with products to be used for serial testing, and a fact sheet that screening program organizers can use to pick the right test.
Biden administration seems to be betting Elluve's OTC at-home antigen diagnostic test will be a game changer in helping stop the spread of the coronavirus.
Cue’s point-of-care molecular test earned an FDA emergency use authorization in June.