Therapy Areas: Respiratory
Quidel's QuickVue At-Home OTC COVID-19 Test Receives Emergency Use Authorization for Screening Use with Serial Testing
1 April 2021 - - US-based rapid diagnostic testing solutions provider Quidel Corp. (NASDAQ: QDEL) has received an Emergency Use Authorization from the US Food and Drug Administration, 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, the company said.

This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nares specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older.

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.

The QuickVue At-Home OTC COVID-19 Test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS-CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020.

Quidel's QuickVue brand launched in 1986 with visually read rapid diagnostics focusing on women's health and respiratory diseases.

In 1999, QuickVue Influenza A+B was the first visually read rapid test approved by the FDA for professional use.

QuickVue was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors' offices, urgent care clinics and pharmacies.

Today, QuickVue is a platform in the professional segment for visually diagnosing Influenza, respiratory syncytial virus, Strep A and a range of other illnesses.

Since the launch of the QuickVue brand into the professional segment, more than 150m QuickVue diagnostic tests have been sold.

Quidel recently started the buildout of a new manufacturing facility in Carlsbad, CA.

The 128,000 square foot facility is expected to be the company's highest-volume production facility and begin operations in the second half of 2021, initially with a mission to produce more than 50m QuickVue rapid antigen tests per month, or 600m tests per year at full capacity.

The QuickVue At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration's Emergency Use Authorization.

The QuickVue At-Home OTC COVID-19 Test has not been FDA cleared or approved.

The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Federal Food, Drug and Cosmetic Act, 21 USC. § 360bbb-3(b) (1), unless the declaration is terminated or authorization is revoked sooner.

Quidel Corp. (NASDAQ: QDEL) is a manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe.

An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the US.

Under trusted brand names Sofia, Solana, Lyra, Triage and QuickVue, Quidel's comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19.

With products made in America, Quidel's mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world.
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