One year into the pandemic, the FDA has authorized its first molecular COVID-19 diagnostic that can be performed completely at home and purchased without a prescription.
Cue Health’s cartridge-based nasal swab test can be used solo or for children as young as two with adult supervision, regardless of whether a person is showing symptoms or suspects that they’ve been exposed directly to the coronavirus.
The kit includes a single-use test and sample collecting wand as well as a battery-powered cartridge reader that connects to a smartphone app. Results are expected within 20 minutes.
“For the first time, consumers can access laboratory-grade testing at home,” said Ayub Khattak, co-founder and CEO of Cue Health, which was recently named one of Fierce Medtech's 2020 Fierce 15.
“With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem,” Khattak said.
In studies, Cue Health’s home test had a false-negative rate of 4% with zero false-positive results. And after raising more than $100 million in funding last year—plus a $481 million U.S. government contract to expand its manufacturing—the company said it expects to be able to produce more than 100,000 tests per day by this summer.
To date, the FDA has authorized more than 330 different COVID-19 tests and sample collection kits, including molecular, antigen and antibody tests for the home, the lab and anywhere in between. The agency has also prioritized the review of diagnostics designed for the point of care as well as those that could help relieve the burden on centralized testing facilities.
The FDA also authorized Adaptive Biotechnologies’ DNA-sequencing blood test that identifies T-cell immune responses to the coronavirus to indicate a recent or prior infection—similar to an antibody test with high accuracy. This can determine whether the body’s white blood cells “remember” a previous exposure to the virus and potentially protect against a future infection.