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Cue Health Files for Full FDA Clearance of COVID-19 Molecular Test

The story has been corrected to state that two COVID-19 tests have so far received FDA clearance.

NEW YORK – Cue Health said on Monday that it has submitted to the US Food and Drug Administration for full clearance of its molecular test for COVID-19 for at-home and point-of-care use.

The firm said it has made a de novo submission to the agency.

The Cue COVID-19 Test received Emergency Use Authorization from the FDA in March 2021. Full clearance from the agency "would provide the public with a molecular COVID-19 test that has been fully reviewed by the FDA for safety and effectiveness," San Diego-based Cue Health said in a statement. It added that in its prior FDA EUA submission, the test demonstrated 98.9 percent accuracy, while an independent Mayo Clinic study showed it had 97.8 percent overall concordance with central lab-based PCR testing.

More than two years into the COVID-19 pandemic, the FDA has recently encouraged test makers to pursue full clearance and/or approval for their COVID-19 tests. To date, only BioMeriéux subsidiary BioFire Diagnostics has had its COVID-19 tests receive clearance from the FDA. Its FilmArray RP2.1 received de novo clearance in March 2021, and its BioFire COVID-19 Test 2 received 510(k) clearance in November 2021.