FDA updates COVID-19 take a look at coverage to chop emergency use requests (NYSE:ABT)

Revising its COVID-19 take a look at coverage, the U.S. Meals and Drug Administration (FDA) mentioned Tuesday that the company would overview solely a small variety of new emergency use authorization (EUA) requests for diagnostic checks.

As a substitute, the FDA urges builders looking for authorizations for his or her checks to pursue the standard pathways for approval by the de novo classification or 510(okay) clearance. Nonetheless, the company will proceed to overview the at the moment pending EUA requests.

Noting that the company has issued EUAs for 430 COVID-19 checks up to now, the FDA mentioned that these checks present ample testing capability all through the U.S.

Given the present degree of the manufacturing capability and client entry to checks, “shifting to conventional premarket overview would finest meet the general public well being wants on the present stage of the COVID-19 public well being emergency,” mentioned Jeff Shuren, director of the FDA’s Heart for Gadgets and Radiological Well being.

Largest producers of fast COVID-19 antigen checks: Becton, Dickinson (BDX), Quidel (QDEL), Abbott Laboratories (NYSE:ABT), Roche (OTCQX:RHHBY) (OTCQX:RHHBF)

Different producers of fast COVID-19 antigen checks: QIAGEN (QGEN), OraSure Applied sciences (OSUR), LumiraDx (LMDX)

Producers of COVID-19 PCR checks: Thermo Fisher Scientific (TMO), PerkinElmer (PKI), Bio-Rad Laboratories (BIO), Co-Diagnostics (CODX), Hologic (HOLX)

At residence COVID-19 PCR take a look at makers: Cue Well being (HLTH)

Makers of COVID-19 antibody checks: Laboratory Corp. of America (LH), Quest Diagnostics (DGX)

The revised coverage marks a shift within the FDA’s priorities because the COVID-19 impression wanes. Final month, the Biden administration introduced plans to transition the government-led procurement and distribution of COVID-19 vaccines and therapeutics to the business market.