Skip to main content
Premium Trial:

Request an Annual Quote

BioMérieux Nabs CE Mark for RT-PCR SARS-CoV-2, Influenza A/B Assay

NEW YORK – BioMérieux said on Wednesday that it has received CE marking for its SARS-COV-2 Respi R-Gene test, which tests for SAR-CoV-2 and other respiratory infections.

BioMérieux's new assay simultaneously detects SARS-CoV-2 and influenza viruses A and B. Within each test kit is a cellular control to check the quality of the sample, and the kit comes with a second real-time PCR analysis to detect human respiratory syncytial virus and human metapneumovirus.

The French firm said that the new assay can be performed by any laboratory using PCR technology on commercially available nucleic acid extraction and amplification platforms. The test can produce results within four to five hours.

"Infections caused by respiratory viruses often have similar symptoms, but patient management may differ," François Lacoste, executive VP of R&D at BioMérieux, said in a statement. "Although the circulation of flu viruses is low to date, in light of the COVID-19 pandemic, it is even more important to detect other diseases associated with respiratory disease early on, especially for high-risk patient groups."

BioMérieux was previously granted Emergency Use Authorization by the US Food and Drug Administration earlier this month for its SARS-CoV-2 assay developed by its subsidiary BioFire Defense for use with pooled samples.

The Scan

Suicidal Ideation-Linked Loci Identified Using Million Veteran Program Data

Researchers in PLOS Genetics identify risk variants within and across ancestry groups with a genome-wide association study involving veterans with or without a history of suicidal ideation.

Algorithm Teases Out Genetic Ancestry in Individuals at Biobank Scale

Researchers develop an algorithm known as Rye to tease apart ancestry fractions in admixed individuals at a biobank-scale, applying it to 488,221 UK Biobank participants in Nucleic Acids Research.

Multi-Ancestry Analysis Highlights Comparable Common Variants at Complex Trait-Linked Loci

Researchers in Nature Genetics examine common variants implicated in more than three dozen conditions, estimating genetic effect similarities across ancestry tracts in admixed individuals.

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.