Skip to main content
Premium Trial:

Request an Annual Quote

BD Gains FDA Clearance for Combination COVID-19, Flu, RSV Molecular Test

NEW YORK – Becton Dickinson said Tuesday that the US Food and Drug Administration has given 510(k) clearance to the firm's combination COVID-19, influenza A/B, and respiratory syncytial virus molecular test. 

Called the BD Respiratory Viral Panel for BD Max, the RT-PCR test uses a single nasal or nasopharyngeal swab to detect and distinguish SARS-CoV-2, influenza A, influenza B, and RSV. The panel can return results in as little as two hours on the company's BD Max molecular diagnostic system.

"Last year, we experienced a threat of a 'tripledemic' with COVID, flu, and RSV circulating simultaneously, and that threat remains for the coming respiratory season," Nikos Pavlidis, VP and general manager for diagnostics at BD, said in a statement. "As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate, and treat patients, and help manage the spread of the infections."

Franklin Lakes, New Jersey-based BD has been selling the panel in the US since receiving FDA Emergency Use Authorization in February. The test was CE marked in May 2022.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.