The government this week cleared the way for the Quidel Corporation (NASDAQ: QDEL), headquartered in Sorrento Valley, to offer its at-home COVID-19 test to the public.
Quidel received the emergency-use authorization from the U.S. Food and Drug Administration for its QuickVue At-Home COVID-19 Test.
The test is authorized for prescription home use with self-collected nasal swabs from those ages 14 years and above. Healthcare providers can prescribe the test for patients believed to have contracted COVID, within the first six days of the onset of symptoms.
It’s also authorized for youngsters ages 8 or above, with adults assigned to collect samples.
The company reports an 85% success rate on positives with the QuickVue at-home test, and 99% on negative results.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in a statement. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”
In addition to this new prescription home test, Quidel also received an emergency-use authorization in December for their QuickVue SARS Antigen Test.
The company’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, which expedited the emergency-use authorization.
Quidel has provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of their Sofia tests last year.
“Quidel’s employees have truly risen to the challenge of the SARS pandemic. 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 Douglas Bryant, the company’s president and CEO, in a statement
The QuickVue At-Home COVID-19 Test has not been FDA cleared or approved. It is authorized only for the detection of proteins from SARS-CoV-2, for the duration of the declaration that allows emergency use of certain diagnostic tests for COVID-19.
In addition to its Sorrento Valley HQ and offices, Quidel is preparing to open a 128,000 square-foot manufacturing site in Carlsbad later this year.