Becton Dickinson Nabs FDA EUA for COVID-19, Influenza, RSV Test

Original from: genomeweb

Becton Dickinson announced on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its combination COVID-19, influenza A/B, and respiratory syncytial virus test. 

The RT-PCR assay runs on the BD Max Molecular Diagnostic System and returns results in as little as two hours from a nasal or nasopharyngeal swab, BD said in a statement. The Respiratory Viral Panel can identify and distinguish whether someone has one of the viruses or some combination of all three. It is authorized for use in laboratories that meet requirements to perform moderate- or high-complexity tests, according to the authorization document from the FDA.

"While fears of a 'tripledemic' this respiratory season have largely diminished, accurately differentiating influenza and RSV from COVID-19 and providing appropriate treatment remains a challenge for our customers," Nikos Pavlidis, VP of molecular diagnostics at BD, said in a statement. The test "provides the ability to identify multiple pathogens using a single sample and can quickly pinpoint the causative virus or viruses and enable clinicians to administer appropriate treatment early in the course of infection."

The test was CE marked in May 2022 and funded in part by federal funds from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority, the Franklin Lakes, New Jersey-based firm said. 

Source: Becton Dickinson Nabs FDA EUA for COVID-19, Influenza, RSV Test