FDA Grants First Marketing Approval for COVID-19 Diagnostic Test

FDA recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) COVID-19 diagnostic test. 

BioFire RP2.1 is used for the simultaneous qualitative detection of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of COVID-19 and other respiratory tract infections. 

The test, which received FDA emergency use authorization last May, is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.

In light of the new approval, FDA has revoked the emergency use authorization for this device. Notably, the emergency use revocation and marketing authorization do not impact the availability of other tests under emergency use authorization. 

“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,”  FDA Acting Commissioner Janet Woodcock, MD, said in the announcement. 

“We will 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,” Woodcock continued. 

BioFire RP2.1 was granted marketing authorization using the De Novo premarket review pathway, which is a regulatory pathway for low- to moderate-risk devices of a new type.

FDA granted approval for the COVID-19 diagnostic test based on additional data showing validation beyond what is needed for emergency use authorization.

Specifically, the agency reviewed data from a clinical study of over 500 test samples and a variety of analytical studies, which showed “reasonable assurance” that BioFire RP2.1 was safe and effective at identifying and differentiating various respiratory viral and bacterial pathogens. 

Positive results of this test do not rule out coinfection, which is when an individual acquires two different viral strains of a disease simultaneously. The agents detected by BioFire RP2.1 may not be the definite cause of disease, FDA noted. 

A negative BioFire RP2.1 result may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that may not be detected by a nasopharyngeal swab.

“Safety, effectiveness and innovation remain important priorities for CDRH. Today’s action underscores the FDA’s ongoing commitment to expand access to testing while providing important safeguards through both our EUA authority and traditional review pathways,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

Along with the De Novo authorization, FDA is establishing criteria, called special controls, that will define the requirements related to labeling and performance testing. 

The special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests similar to BioFire RP2.1.  

At the end of March 2020, FDA Commissioner Stephen M. Hahn, MD, provided an update on the review processes and procedures for the authorization of COVID-19 diagnostic tests.

The update emphasized that FDA will continue to work with test developers during the pandemic to slow and ultimately tackle the virus. Additionally, the agency revised the testing process to allow labs to begin testing prior to FDA review of their validation data. 

Since the updates were implemented, FDA has authorized for use the Quest Diagnostics RC COVID-19 + Flu RT-PCR Test, Ellume’s over-the-counter COVID-19 diagnostics test, and the Yale School of Public Health’s SalivaDirect COVID-19 diagnostic test.
Most recently, FDA issued an emergency use authorization for a sequencing-based COVID-19 diagnostic test, the T-Detect COVID Test, developed by Adaptive Biotechnologies.