Agency Opens Premarket Pathway for Post-Emergency COVID-19 Test Marketing

The public health emergency that began last February will eventually end. But the demand for COVID-19 tests will not. The transition from the emergency to post-emergency test market unofficially began on March 17, 2021 when the FDA cleared a COVID-19 via its traditional premarketing pathway for the very first time.

BioFire FilmArray RP2.1 Panel Gets De Novo Clearance

Up to now, all of the several hundred COVID-19 tests that have reached the U.S. market have come through the FDA Emergency Use Authorization (EUA) pathway. EUA offers the advantage of expedited clearance; the downside is that EUA clearance ends when the emergency does. Of course, traditional premarket pathways allowing for marketing beyond the emergency have been available all of this time. And 13 months into the emergency, a COVID-19 test maker has used it.

The first test to make the transition from EUA to de novo clearance status is BioFire Diagnostics’ BioFire FilmArray Respiratory Panel (RP) 2.1, which detects 22 different viruses and bacteria associated with SARS-CoV-2 and other respiratory tract infections from a singly nasopharyngeal swab in 45 minutes. The FilmArray RP2.1, which was originally granted EUA clearance on May 1, 2020 (that EUA clearance has now been officially revoked as part of the transition to de novo status) runs on the firm’s FilmArray 2.0 and higher-throughput BioFire Torch systems. BioMérieux subsidiary BioFire has developed a suite of SARS-CoV-2 diagnostic products, including, among others, a singleplex assay for the FilmArray system and the RP 2.1-EZ Panel that detects the coronavirus and 18 other pathogens in point of care and near patient CLIA-waived settings.
The FDA noted that it based its decision to grant de novo clearance, in part, on a review 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.”

Impact on Future COVID-19 Test Development

The FDA specifically noted that the FilmArray RP2.1 EUA revocation and de novo authorization don’t affect the availability of other EUA tests. However, while the EUA pathway remains open, the first de novo clearance of a COVID-19 test signals that the traditional premarket pathway is also open to test makers looking to develop coronavirus products for the post-pandemic market. “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,” noted FDA acting commissioner Janet Woodcock in a statement.

The FilmArray RP2.1 de novo clearance also creates a new regulatory classification, which, according to the agency, “means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.”

Here are the other key new FDA EUAs and clearances announced in March:

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Other international clearances announced during the period:

New FDA Emergency Use Authorizations (EUAs) & Approvals