In a first for the industry, FDA has granted marketing authorization to a SARS-CoV-2 test using the De Novo premarket review pathway. On Wednesday, the agency announced BioFire Diagnostic’s Respiratory Panel 2.1 had won De Novo designation.

Previously, the Salt Lake City, UT-based company’s test had won emergency use authorization – a designation nearly all of the COVID-19 related tests during the pandemic era have been awarded. (Editor’s note: bioMérieux acquired BioFire Diagnostics in 2014 for $450 million plus milestones.)

The granting of the De Novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens.  

“Today’s action is a great demonstration of FDA’s work to protect the public health in emergency response situations and beyond,” said FDA Acting Commissioner Janet Woodcock, MD. “We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities. While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways.”

The Biofire RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The Biofire RP2.1 Panel yields results in about 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. It runs on the fully automated Biofire Filmmarry 2.0 and Biofire Torch Systems with only 2 minutes of sample preparation time.

This De Novo designation is significant because it is establishing criteria called special controls that define the requirements related to labeling and performance testing. It also establishes new regulatory classification.