First FDA De Novo Clearance Signals That Premarket Pathway Is Open for COVID-19 Tests

Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new phase when the agency cleared a COVID-19 diagnostic via its traditional premarketing pathway for the very first time, thus allowing for marketing of the test beyond the public health emergency.

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.” Data from a clinical study of more than 500 samples was apparently a major factor in the agency’s determination. A BioMeriéux statement described it as a multicenter prospective clinical study combining reference of three independent EUA molecular SARS-CoV-2 assays. According to the company, the panel demonstrated positive percent agreement of 98 percent and negative percent agreement of approximately 99 percent.

Impact on Future COVID-19 Test Development

The EUA pathway remains open. Thus, the FDA specifically noted that the FilmArray RP2.1 EUA revocation and de novo authorization do not affect the availability of other EUA tests. However, the move serves notice that COVID-19 test makers can also use the traditional premarket pathway if they are looking to develop 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 agency is also working on potential new pathways, including via the establishment of “special controls” for labeling and performance testing. “When met,” the FDA explained, “these controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.”

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.”

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This article originally appeared in G2 Intelligence, Diagnostic Testing & Emerging Technologies, April 2021.