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 ...

This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in ...

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...

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 ...

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 ...

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 ...

Narrow-moat BioMerieux reported strong third-quarter results, with reported growth of 21% (26.5% at constant currency) driven by 120% product line growth of BioFire respiratory panel 2.1, a syndromic ...

(RTTNews) - As we enter the second quarter of the year, it's time to take a look back at some of the news stories that made headlines on the regulatory front in March. BioFire Respiratory Panel 2.1 ...

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 ...

For the first year of the pandemic, the FDA worked hard to make it clear that each green light it gave to a COVID-19 diagnostic test kit—over 340 to date—amounted to only an emergency authorization ...