FDA grants its first full approval to a COVID-19 diagnostic test

For the first year of the pandemic, the FDA worked hard to make it clear that each green light it gave to a COVID-19 diagnostic test kit—over 340 to date—amounted to only an emergency authorization and not a full approval, meaning it had not been reviewed to its highest standards and could only be used for a limited time as the country fought off the pandemic.

Now, the agency has granted its first official endorsement, allowing a respiratory panel test from BioFire Diagnostics to be sold into the foreseeable future. 

The diagnostic is designed to screen deep nasal swab samples for multiple infections to help identify coronavirus cases among people with symptoms similar to the flu, respiratory syncytial virus and the bugs behind the common cold.

“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,” said the FDA’s acting commissioner, Janet Woodcock, M.D., the longtime head of the agency’s drug center.

At the same time, the FDA streamlined its review process for granting emergency use authorizations in the first place, aimed at cultivating broad COVID-19 screening programs at schools, workplaces, communities and other locations—where individuals may be tested repeatedly to catch new cases as they appear. 

This includes new regulatory submission templates for developers of tests for the laboratory and points of care as well as out in the field, such as in sports venues or airports.

“We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing,” the FDA said in a statement

BioFire’s test, meanwhile, received a de novo clearance, which creates a simpler pathway to approval for other coronavirus diagnostics. Future tests would only have to prove they are substantially equivalent to the first approved product. The company’s RP2.1 test was previously granted an emergency authorization in May 2020; however, additional lab testing may be needed, such as bacterial or viral cultures, to confirm an individual patient’s infection.