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

Two years after its cartridge-based diagnostic became the first COVID-19 test given emergency use authorization by the FDA for non-prescription, at-home use, Cue Health has now scored the agency’s first regular-use clearance for an at-home COVID test.

Cue announced the de novo clearance for its molecular test on Tuesday. According to the company, not only does the green light represent a milestone in COVID diagnostics, but it’s also the first de novo clearance issued for a home-use test for any respiratory disease.

The nod ushers in “a new era of consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in an agency statement.

“The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities,” Shuren continued. “This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”

Cue’s testing system comprises a portable, battery-powered PCR analyzer and single-use test cartridges. Users place a nasal swab sample in a cartridge, which is in turn inserted into the analyzer. After about 20 minutes, the analyzer sends the test results to the Cue Health app on a connected smartphone. A 2021 Mayo Clinic study found that the Cue system’s results matched up with reference testing nearly 98% of the time.

The system’s full market clearance comes after the FDA began asking test makers to pursue traditional regulatory pathways for their COVID diagnostics, as the agency winds down its emergency authorizations amid the end of the official coronavirus public health emergency.

Only a few have risen to the challenge so far. The first de novo nod for a COVID test went to BioFire Diagnostics in March 2021—for its lab-based, 22-pathogen respiratory panel—opening up a new 510(k) route that resulted in a handful of additional PCR test clearances for Roche, DiaSorin Molecular and more.

More recently, in March of this year, QuidelOrtho announced that it had secured the inaugural de novo clearance for a rapid antigen COVID test. The prescription-only Sofia 2 SARS Antigen+ FIA is designed for point-of-care use, and its tabletop analyzer returns results within just 10 minutes.

Cue’s achievement also comes as the company shifts its focus beyond the coronavirus. So far this year, the test maker has earned an emergency use authorization from the FDA for its point-of-care mpox diagnostic and submitted a de novo clearance application for its RSV molecular test. It’s also in the process of wrapping up clinical studies of two more tests, one for strep and one to detect chlamydia and gonorrhea, both of which are set to be submitted for FDA review later this year.

Alongside that expansion in its diagnostic offerings, however, Cue has taken steps to slim down its operations as profits from COVID tests have waned. Those cost reduction efforts began last year and included layoffs of about 14% of its workforce; in a first-quarter earnings report issued last month, Cue said it had reached its goal of $100 million in cost savings ahead of schedule and had begun seeking out an additional $50 million in cuts.