NEW YORK — Becton Dickinson said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a PCR-based test that can detect SARS-CoV-2 and the influenza A and B viruses.
The test has also received CE marking, BD said.
The BD SARS-CoV-2/Flu assay runs on the firm's BD Max platform and provides a positive or negative result for each virus using a single specimen within three hours.
"Since COVID-19 and Flu often present with similar symptoms, such as fever and dry cough, having a single specimen for accurate diagnosis speeds time to results and helps clinicians determine the right care more quickly to help prevent community transmission," Charles Cooper, vice president of medical and scientific affairs for integrated diagnostic solutions at BD, said in a statement.
COVID-19 has been an increasingly important part of BD's commercial focus, with its suite of molecular and antigen tests for SARS-CoV-2 contributing $867 million to the $5.32 billion in revenues the company reported for its fiscal first quarter. Earlier this year, Franklin Lakes, New Jersey-based BD said that is now exploring home-use and over-the-counter SARS-CoV-2 testing indications.