NEW YORK – BioMeriéux subsidiary BioFire Diagnostics has been granted de novo clearance from the US Food and Drug Administration for its Respiratory Panel 2.1, the agency said on Wednesday. The test is the first SARS-CoV-2 diagnostic to transition from an Emergency Use Authorization status and be permitted to be marketed beyond the public health emergency.
Janet Woodcock, FDA acting commissioner, called the de novo clearance "a great demonstration" of the FDA's efforts to protect public health.
"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 said in the statement.
The BioFire FilmArray RP2.1 detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab. It yields results in 45 minutes with two minutes of hands-on time and can be run on the firm's fully automated FilmArray 2.0 as well as the higher-throughput BioFire Torch systems.
The FilmArray RP2.1 was originally authorized under the Emergency Use pathway in May, 2020. Prior to that, the firm obtained EUA for a singleplex SARS-CoV-2 test it developed for the FilmArray system.
BioMeriéux also markets the RP 2.1-EZ Panel that identifies 19 pathogens including SARS-CoV-2 in point of care and near patient CLIA-waived settings, as well as RT-qPCR tests called Argene SARS-CoV-2 R-GENE and SARS-CoV-2 RESPI R-GENE, the latter also detecting influenza targets.
In its statement, FDA noted that the de novo clearance was based in part on a review of data from a clinical study of more than 500 samples as well as other 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."
In a separate statement, BioMeriéux said that the firm's multicenter prospective clinical study combined reference of three independent EUA molecular SARS-CoV-2 assays, and that the panel demonstrated positive percent agreement 98 percent and negative percent agreement of approximately 99 percent.
As part of the transition to de novo clearance, the EUA status for the BioFire FilmArray RP2.1 has been revoked. The FDA noted, however, that the EUA revocation and de novo authorization do not impact the availability of other tests under EUA.
FDA also noted that, along with this de novo authorization, the agency is establishing special controls that define the requirements related to labeling and performance testing.
"When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type," FDA said.
In addition, this action also creates a new regulatory classification, "which 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," FDA said.