Yahoo Finance

WellStreet Urgent Care, bioMérieux celebrate 200,000 patients served through BIOFIRE® SPOTFIRE® tests in urgent care clinics across Georgia, Ohio and South Carolina

ATLANTA and SALT LAKE CITY, Dec. 18, 2025 /PRNewswire/ -- WellStreet Urgent Care, an expert in developing and scaling urgent care networks with health system partners, and bioMérieux, a world leader ...
News Medical

FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway

Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and ...
Nasdaq

bioMérieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary ...
usace.army.mil

USAMMDA Announces FDA 510 (k) Clearance of Rapid Diagnostic Test for COVID-19

The U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office, along with its commercial partner BioFire Defense, announced the U.S. Food and ...
MD&M East

A Major Turning Point for COVID-19-Related Diagnostics

In a first for the industry, FDA has granted marketing authorization to a SARS-CoV-2 test using the De Novo premarket review pathway. On Wednesday, the agency announced BioFire Diagnostic’s ...
The Digital Universe

Utah company develops first fully FDA-authorized COVID-19 test

A BYU life science student works with COVID-19 samples. A Utah lab called BioFire developed the first fully FDA-approved COVID-19 test. (Todd Jackson) A biotech company from Utah has developed the ...