BioCentury
ARTICLE | Product Development

Cue’s OTC home molecular test opens the door to routine self-screening

March 6, 2021 1:02 AM UTC

FDA’s first authorization of an over-the-counter molecular test marks a turning point for COVID-19 screening via a system that encourages repeat home testing.

Performance metrics reported by manufacturer Cue Health Inc. also suggest the test, which uses isothermal nucleic acid amplification to detect viral genomic material, is more sensitive than previously authorized at-home tests, including those detecting viral proteins...