Regulatory Cue Health racks up FDA's first de novo nod...

Cue Health racks up FDA’s first de novo nod for an at-home COVID test


Cue Health has received the FDA’s first approval for regular use of a COVID-19 at-home test, two years after the agency granted emergency use authorization for the company’s cartridge-based medication solution.

The company said that their molecular test had received de novo clearance. The company claims that in addition to being a significant development for COVID diagnostics, the approval also marks the first de novo clearance for a home-use test for a respiratory condition.

According to Jeff Shuren, Unit head at the FDA’s radiological division, the approval heralds the beginning of a new era of consumer access to diagnostic tests that can be entirely performed at home. The FDA continues to actively collaborate with test developers who want to sell their devices outside emergency use authorization. This is a component of a larger FDA initiative to accelerate the creation and accessibility of at-home tests for a range of medical disorders in order to widen access to patient testing.

A portable, battery-operated PCR analyzer and single-use test cartridges make up Cue’s testing equipment. Users enter a cartridge containing a nasal swab sample into the analyzer. The analyzer provides the test results to the Cue Health app on a linked smartphone within 20 minutes. According to Mayo Clinic Research statistics, the results of the Cue system correlated with reference tests in over 98% of cases.

The FDA started forcing test manufacturers to follow conventional regulatory paths for their COVID diagnostics as the agency wound down its emergency authorizations, despite the formal conclusion of the coronavirus public health emergency, and this led to the system’s full market approval. A few people have accepted the challenge. In March 2021, BioFire Diagnostics received the first de novo nod for a COVID test for their lab-based, 22-pathogen respiratory panel. This cleared a new 510(k) pathway and led to the clearance of a few other PCR tests from Roche, DiaSorin Molecular, and other companies.

QuidelOrtho recently disclosed that it has obtained the first de novo clearance for a fast antigen COVID test. The point-of-care Sofia 2 SARS Antigen+ FIA, which is only available with a prescription, has a tabletop analyzer that provides results within 10 minutes.

Additionally, Cue’s success comes as the business broadens its focus outside the coronavirus. The manufacturer of the test has so far this year submitted a de novo clearance application for its RSV molecular test and received an emergency use authorization from the FDA for both of its point-of-care mpox diagnostics.

It is also nearing completion of clinical trials for two other tests, one for strep and the other for the detection of chlamydia and gonorrhea, both of which will be submitted for FDA approval later this year. Cue has taken attempts to streamline its operations, in addition to developing its diagnostic capabilities, as COVID test earnings have decreased. Approximately 14% of its workforce was laid off as part of the cost-cutting initiatives.

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