Achieving FDA De Novo Authorization
This year, the BioFire RP2.1 Panel became the very first respiratory panel to be granted FDA De Novo marketing authorization for the detection of SARS-CoV-2. The BioFire RP2.1 Panel is a multiplex PCR test that targets 22 viruses and bacteria—including SARS-CoV-2, influenza, RSV, and other common causes of respiratory infections—in about 45 minutes.
While SARS-CoV-2 remains top of mind for healthcare providers and patients, respiratory infections have many causes. A syndromic respiratory pathogen panel like the BioFire RP2.1 Panel can provide fast, comprehensive answers on causes of infection as well as co-infection.
During future respiratory seasons, SARS-CoV-2 will still be around, even as vaccinations increase and spread decreases. That’s why syndromic testing from BioFire is an excellent choice for respiratory season and beyond. By targeting the most probable causes of overlapping respiratory symptoms, the BioFire RP2.1 Panel empowers healthcare providers to choose the right test, the first time.