Skip to main content
Premium Trial:

Request an Annual Quote

BioMérieux BioFire Respiratory Panel With SARS-CoV-2 Target Nabs CE Mark

NEW YORK – BioMérieux announced Wednesday that its BioFire Respiratory Panel 2.1 plus, which tests for SARS-CoV-2 and other respiratory infections, received CE marking.

The panel tests for 23 pathogens encompassing 19 viruses, including SARS-CoV-2 and Middle East Respiratory Syndrome Coronavirus, and four bacteria that result in the most frequent respiratory tract infections. The new test, whose earlier version received Emergency Use Authorization from the US Food and Drug Administration in May, adds SARS-CoV-2 to the BioFire Respiratory Panel 2 plus with the same runtime of approximately 45 minutes, the firm said. 

The company said in a statement the test will be available in all countries recognizing CE marking starting now or "shortly thereafter." It runs on the BioFire FilmArray 2.0 and BioFire FilmArray Torch systems, and CEO Pierre Boulud said there are more than 14,000 BioFire units installed globally.

In March, the company received EUA for subsidiary BioFire Diagnostics' rapid COVID-19 assay that runs on both FilmArray systems. In May, the firm received EUA for its high-complexity molecular diagnostic test for SARS-CoV-2. 

The Scan

Quality Improvement Study Compares Molecular Tumor Boards, Central Consensus Recommendations

With 50 simulated cancer cases, researchers in JAMA Network Open compared molecular tumor board recommendations with central consensus plans at a dozen centers in Japan.

Lupus Heterogeneity Highlighted With Single-Cell Transcriptomes

Using single-cell RNA sequencing, researchers in Nature Communications tracked down immune and non-immune cell differences between discoid lupus erythematosus and systemic lupus erythematosus.

Rare Disease Clues Gleaned From Mobile Element Insertions in Exome Sequences

With an approach called MELT, researchers in the European Journal of Human Genetics uncovered mobile element insertions in exomes from 3,232 individuals with or without developmental or neurological abnormalities.

Team Tracks Down Potential Blood Plasma Markers Linked to Heart Failure in Atrial Fibrillation Patients

Researchers in BMC Genomics found 10 differentially expressed proteins or metabolites that marked atrial fibrillation with heart failure cases.