FDA GIVES QUIDEL EMERGENCY AUTHORIZATION FOR COVID TEST
San Diego’s Quidel Corp. got the green light this week for its home-use COVID-19 diagnostic test with a prescription — an incremental step toward the company’s goal of offering rapid COVID tests over the counter at pharmacies and other retailers.
The U.S. Food and Drug Administration on Monday granted Emergency Use Authorization for the QuickVue At-Home COVID-19 Test for people with symptoms and a doctor’s approval. The antigen test delivers results in 10 minutes.
With QuickVue, a self-collected nasal swab sample is added to a liquid solution that comes in the QuickVue kit. Then a test strip is inserted into the solution and yields a color coded positive or negative result, akin to a pregnancy test. No other equipment is required.
In December, Quidel received Emergency Use Authorization from the FDA to use its COVID QuickVue tests in hospitals, physicians’ offices and urgent care clinics, with medical personnel collecting nasal swabs.
This week, it got the go-ahead for QuickVue for people with symptoms to collect samples themselves at home as long as the test is prescribed by a doctor.
QuickVue is authorized for use by people 14 years and older. It also can be used on children as young as 8, but an adult must collect the sample.
In a clinical study, QuickVue’s positive COVID results matched gold standard PCR tests 84.8 percent of the time, while its negative results were confirmed by PCR 99.1 percent of the time.
The company has yet to say where QuickVue At-Home COVID-19 Tests will be sold or the price.
Ultimately, Quidel plans to seek FDA authorization for QuickVue At-Home tests that are sold over the counter without a prescription — not only for COVID-19 but other ailments such as the flu and strep.
For COVID, those over-thecounter efforts have been delayed as Quidel attempts to prove its tests can uncover positive results in asymptomatic people per FDA standards.
“The delay does not portend any issue but rather stems from the lack of asymptomatic positive cases in the existing cohort” of test subjects, said Andrew Cooper, an analyst with Raymond James, in a recent research report. “Quidel has added additional trial sites to help find more of the required patients.”
Once it gathers this additional data, the company plans to seek FDA authorization for the overthe-counter test, according to a company spokeswoman.
“Our mission is to provide greater access to frequent, affordable and highly accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones,” said Quidel Chief Executive Douglas Bryant in a statement. “This is an important first step in a twostep process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.”
The company is making a big bet on at-home testing. It is building out a new, 128,000-square-foot manufacturing facility in Carlsbad, which is expected to begin making QuickVue tests this summer. Eventually, Quidel aims to make more than 50 million QuickVue tests per month at the facility.
Quidel isn’t alone in pursuing at-home COVID testing. Lucira Health and Abbott Labs secured clearance late last year for at-home tests with a prescription. Australia-based Ellume also received FDA approval for the first over-thecounter COVID test without a prescription in mid-December and has begun ramping up production.
While at-home testing has its skeptics, who say the results are less accurate than lab-based tests and therefore lead to more misdiagnoses, supporters believe the widespread availability of easy to use at-home tests is a key tool for resuming normal activities.