BD Gets CE-IVD Mark For Molecular Diagnostic Combination Test

Becton, Dickinson (BD) has gained a CE-IVD mark for its BD MAX RVP (respiratory viral panel), a combined molecular diagnostic test for detecting SARS-CoV-2, Influenza A and B and Respiratory Syncytial Virus (RSV).

The combined test uses a single nasal or nasopharyngeal swab sample, which avoids the need for multiple separate tests or doctor visits and “can help clinicians to implement the right treatment plan quickly,” the company said.

The test runs on the company’s high-throughput BD MAX real-time polymerase chain reaction equipment that can process hundreds of samples in 24 hours and deliver results on samples within approximately two hours.

The BD MAX RVP test is now available in countries that recognize the CE mark. The company said it plans on submitting an Emergency Use Authorization request to the FDA in the coming weeks.