The BioFire Respiratory 2.1 Panel was the first respiratory panel to be granted FDA De Novo marketing authorization for SARS-CoV-2 detection. This is how we made it possible and what’s next for the BioFire RP2.1 Panel.
Since the start of the COVID-19 pandemic over a year ago, so much has changed—not only in the realm of infectious disease diagnostics, but for everyday people all around the world. The novel coronavirus—severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2—is the virus responsible for COVID-19. Since late 2019, SARS-CoV-2 has been responsible for over 140 million confirmed infections and over 3 million deaths worldwide.1
Learn more about the history of coronaviruses and human infection here.
Here at BioFire Diagnostics, we shifted our focus at the onset of the pandemic to developing and distributing a rapid COVID-19 diagnostic solution. By adding an accurate SARS-CoV-2 assay to our existing respiratory pathogen panel, we harnessed the power of syndromic testing to combat the threat of COVID-19. In just 40 working days from start to finish, the BioFire RP2.1 Panel was granted FDA Emergency Use Authorization (EUA) for the detection of SARS-CoV-2. The BioFire RP2.1 Panel menu also includes the 21 other pathogens on the BioFire® FilmArray® Respiratory 2 Panel menu.
Amidst unprecedented pressure on global healthcare systems, we also experienced unprecedented demand for our respiratory pathogen testing solutions at BioFire. In April 2020, we opened a new manufacturing building and began new production lines shortly thereafter. We doubled the number of full-time employees in many of our manufacturing lines and were able to increase reagent production by more than 20% and counting.
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.
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Remembering Thomas Brock, the Scientist Who Transformed Biotechnology