FDA Approves First COVID Test Under Traditional Premarket Process

FDA has authorized a home COVID-19 test through its traditional premarket review, rather than the emergency authorization pathway, for the first time, the agency announced Tuesday (June 6). The Cue COVID-19 Molecular Test, a molecular nucleic acid amplification test (NAAT) intended to detect genetic material from the SARS-CoV-2 virus present in nasal swabs, is the first at-home test for a respiratory virus granted traditional authorization, FDA says in a statement . The marketing authorization was granted to Cue Health Inc...