QuidelOrtho Gains De Novo Authorization for COVID-19 Test

QuidelOrtho has received FDA’s de novo authorization for its Sofia 2 SARS Antigen+ FIA rapid test for COVID-19 — making it the first antigen test for COVID-19 to gain a full authorization rather than an emergency use authorization from the agency.

The immunofluorescent assay, which detects antigens gathered from direct anterior nasal swab specimens from symptomatic individuals within six days of symptom onset, provides automated results in 10 minutes.

The assay runs on the company’s Sofia 2 analyzer and is for use by clinical laboratories and in point-of-care settings.

The FDA’s de novo review pathway is for moderate risk devices for which there are no predicate products approved or cleared by the agency for the U.S. market.