Quidel Receives Emergency Use Authorization for QuickVue® SARS Rapid Antigen Test for COVID-19 Diagnosis
Quidel’s new QuickVue SARS Antigen test requires no supplemental instrumentation and is visually read. It offers excellent performance for the detection of SARS-CoV-2 (96.6% PPA versus PCR and 99.3% NPA versus PCR) in anterior nares swab samples, yielding results in just 10 minutes, thereby providing quick, reliable results to patients, their families and healthcare workers alike.
“We are proud to introduce yet another powerful diagnostic tool to aid the fight against COVID-19,” said Douglas Bryant, president and CEO of Quidel Corporation. “The QuickVue® rapid antigen test for coronavirus leverages our proven QuickVue® visually read diagnostic platform for influenza A+B to further democratize access to affordable and highly accurate COVID-19 testing across a diverse range of medical and point-of-care locations.”
“The flexibility of QuickVue® for meeting the urgent testing needs of everyone from school systems to rural areas and even locations without electricity gives us the opportunity to do enormous good in communities across our nation and the world,” Mr. Bryant noted. “We will scale immediately to supply the more than 30,000 QuickVue® professional market customers we serve today and look forward to extending the benefits of this technology as broadly and rapidly as possible in the months and years ahead.”
Quidel plans to reach a production run rate of 600 million QuickVue® tests per year by the end of 2021.
Quidel was the first company to receive EUA from the FDA for a rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against the coronavirus pandemic.
Quidel developed the first visually read lateral flow flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. 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.
QuickVue® is a market leading platform for visually diagnosing Influenza, respiratory syncytial virus (RSV), Strep A and a variety of other illnesses. Since its approval in 1999, more than 150 million QuickVue® units have been sold.
Sofia® 2 is Quidel’s best-selling cartridge-based, instrument-read rapid diagnostic system for infectious disease testing, which utilizes fluorescent chemistry design, an intuitive graphical user interface, and optics system to provide a highly accurate, objective and automated result in 15 minutes. The Sofia® 2 system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data to public health authorities in near real-time.
Quidel recently doubled its production of Sofia® rapid antigen tests to the current rate of approximately two million tests per week. Quidel is building additional production lines that will more than double its current capacity once again. Quidel’s goal is to reach a run-rate of over 240 million Sofia® tests per year by the third quarter of 2021.
It is noteworthy that Quidel’s QuickVue® and Sofia® SARS Antigen test kits are made in San Diego, California.
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading 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 U.S. 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. For more information about Quidel, visit quidel.com.
This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. 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Source: Quidel Corporation