Quidel’s QuickVue At-Home OTC COVID-19 Test Receives Emergency Use Authorization for Screening Use With Serial Testing

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its new QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two (or three days) with at least 24 hours (and no more than 36 hours) between tests. This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nares (NS) specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. Additional information regarding the intended use of the QuickVue At-Home OTC COVID-19 Test can be found at www.quidel.com.

The QuickVue At-Home OTC COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors. This EUA allows the QuickVue At-Home OTC COVID-19 Test to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.¹

“Quidel and the people we serve through our advanced diagnostic technologies all owe a debt of gratitude to the FDA, CDC and NIH for their tireless and thorough pursuit of the science and the algorithms to guide accurate and equitable COVID-19 testing protocols that will catch infections early and help contain virus spread,” said Douglas Bryant, president and CEO of Quidel Corporation. “Studies are confirming that serial testing with rapid antigen tests is a crucial resource for people to know their current health status and make prudent decisions to protect themselves, their loved ones and their communities.”