Dive Brief:

• The U.S. Food and Drug Administration has granted de novo clearance to the Cue COVID-19 Molecular Test, the first at-home, over-the-counter test for COVID-19 to use the traditional premarket review pathway.
• The authorization represents “a new era of consumer access to diagnostic tests that can be performed entirely at home,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.
• The FDA’s nod comes just days after Goldman Sachs downgraded Cue, expressing doubts about Cue’s ability to generate sustainable revenue.

Dive Insight:

Transitioning COVID-19 tests from emergency use authorization to the traditional pre-market pathway has long been a goal for the FDA. 

“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” Shuren said in a statement. “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 molecular test uses a disposable cartridge, a single-use nasal swab, and a cartridge reader device, which is linked to Cue’s own app that displays results when the test is complete, and takes about 20 minutes. In a study reviewed by the FDA, the Cue test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection, the regulator said.

Despite the authorization, Cue faces stiff commercial challenges. In a note to investors this week, analysts at Goldman Sachs warned that with declining demand for COVID-19 tests, switching focus to other tests will mean taking on “a competitive Point of Care (PoC) market where larger companies with financial resources have an established installed base that may be difficult to displace.”

Cue won attention for its device when it was selected by the National Basketball Association to test players when the league held its 2020-21 season quarantined in the NBA Bubble at Disney World in Florida.

Along with Cue’s de novo authorization, the FDA said it is establishing “special controls” that will provide consumers a ”reasonable assurance” of safety and effectiveness for tests of this type. It is also creating a new regulatory classification, so that similar devices can use the FDA’s 510(k) pathway by showing they are substantially the same as a previously approved device.