Logo

BioFire

BioMérieux Gets Health Canada Approval for Updated BioFire Blood Culture ID Panel

The panel includes additional pathogen targets and resistance genes, as well as revised targets compared to the original BCID panel.

BioMérieux Joint Infection Panel Gets FDA De Novo Authorization

The 39-target panel runs on FilmArray systems and tests for 31 pathogens implicated in most acute joint infections as well as eight antimicrobial resistance genes.

BioMérieux Reports 8 Percent Revenue Growth in Q4

The firm is expecting an overall sales decline in 2022 due to decreased demand for COVID-related products as the disease becomes endemic.

Co-Diagnostics to Seek FDA EUA for At-Home PCR Diagnostic System, COVID Test in Q1
Premium

Newly merged with a firm founded by BioFire Diagnostics alums, Co-Diagnostics plans to develop small panels for the system with up to six targets.

Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material

The process control contains 43 intact, inactivated bacteria, yeasts, and antimicrobial resistance targets to validate the syndromic PCR sepsis panel.

Sep 1, 2021

BioMérieux H1 Revenues Rise 7 Percent

Jul 26, 2021

CDC to Withdraw EUA for COVID-19 Test; FDA Revokes Three Other EUAs for Non-Use, Agency Clearance

Mar 18, 2021

BioFire Dx Receives First FDA Marketing Clearance for SARS-CoV-2 Respiratory Panel

Jan 8, 2021

SARS-CoV-2 Mutations Present Unexpected Opportunities, Challenges for MDx Developers
Premium

Dec 30, 2020

Roche Diagnostics, Beckman Coulter, BioMérieux, Mesa Biotech Receive FDA 510(k) Clearances in November

Dec 8, 2020

BioMérieux Coronavirus Test Gets FDA OK for Use With Pooled Samples

Nov 6, 2020

Multiplex PCR Panels for Joint Infections on the Horizon

Oct 22, 2020

BioMérieux Q3 Revenues Increase 21 Percent

Oct 6, 2020

BioFire Diagnostics, UMass Medical Coronavirus Tests Get FDA Emergency Use Authorization

Jul 9, 2020

BioMérieux Reports 62 Percent BioFire FilmArray Sales Growth in Preliminary Q2 Release

May 19, 2020

BioMérieux's BioFire Pneumonia Panel Could Improve Care, Find Secondary Infection in COVID-19 Cases

May 4, 2020

BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Wins FDA Emergency Use Authorization

Apr 16, 2020

BioMérieux Reports 22 Percent Q1 Revenue Growth, Withdraws Full-Year Guidance

Mar 24, 2020

BioMérieux Rapid Coronavirus Test Gets FDA Emergency Use Authorization

Mar 20, 2020

Commercial Coronavirus Test Developers Tweak Timelines, EUA Plans in Light of Loosened FDA Guidance

Mar 18, 2020

BioMérieux's BioFire Diagnostics Sued; Coronavirus Tests Accused of Infringing Theranos Patents

Mar 5, 2020

Coronavirus Dx Emergency Use Authorizations Progressing Rapidly Despite Criticism

Feb 26, 2020

BioMérieux Reports 11 Percent Revenue Growth in Q4

Feb 11, 2020

Qiagen Readying Updated Respiratory Panel for Emergency Coronavirus Testing

Jan 14, 2020

BioMérieux Submits 43-Target BCID2 Test to FDA