hapabapa
Revising its COVID-19 test policy, the U.S. Food and Drug Administration (FDA) said Tuesday that the agency would review only a small number of new emergency use authorization (EUA) requests for diagnostic tests.
Instead, the FDA urges developers seeking authorizations for their tests to pursue the traditional pathways for approval through the de novo classification or 510(k) clearance. However, the agency will continue to review the currently pending EUA requests.
Noting that the agency has issued EUAs for 430 COVID-19 tests so far, the FDA said that these tests provide adequate testing capacity throughout the U.S.
Given the current level of the production capacity and consumer access to tests, “shifting to traditional premarket review would best meet the public health needs at the current stage of the COVID-19 public health emergency,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
Largest manufacturers of rapid COVID-19 antigen tests: Becton, Dickinson (BDX), Quidel (QDEL), Abbott Laboratories (NYSE:ABT), Roche (OTCQX:RHHBY) (OTCQX:RHHBF)
Other manufacturers of rapid COVID-19 antigen tests: QIAGEN (QGEN), OraSure Technologies (OSUR), LumiraDx (LMDX)
Manufacturers of COVID-19 PCR tests: Thermo Fisher Scientific (TMO), PerkinElmer (PKI), Bio-Rad Laboratories (BIO), Co-Diagnostics (CODX), Hologic (HOLX)
At home COVID-19 PCR test makers: Cue Health (HLTH)
Makers of COVID-19 antibody tests: Laboratory Corp. of America (LH), Quest Diagnostics (DGX)
The revised policy marks a shift in the FDA’s priorities as the COVID-19 impact wanes. Last month, the Biden administration announced plans to transition the government-led procurement and distribution of COVID-19 vaccines and therapeutics to the commercial market.