Quidel Receives Emergency Authorization for First Rapid Antigen “ABC Test”

Quidel Corporation announced today that Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 Flu + SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

The new Sofia® 2 Flu + SARS Antigen FIA offers excellent performance for SARS-2 (95.2% PPA versus PCR and 100% NPA versus PCR), as well as for Influenza A (90% sensitivity versus culture and 95% specificity versus culture) and Influenza B (89% sensitivity versus culture and 96% specificity versus culture) in nasal swabs. Quidel’s new Sofia® test delivers a fast, highly accurate result for all three viruses from one nasal swab (or nasopharyngeal swab) sample in just 15 minutes, providing critical answers to patients and healthcare workers alike.

Douglas Bryant, president and CEO of Quidel Corporation Said: As the COVID-19 pandemic converges with seasonal influenza, public health experts face the potential for a ‘perfect storm’ of patients exhibiting similar but distinct medical conditions that require different treatment methods, It is essential for doctors to know what they’re dealing with quickly.

Dr. John Fallon, Medical Director, Vidant Healthcare System Says: This new three-way test to identify and separate influenza strains from coronavirus has arrived just in time for flu season, Quidel has achieved a diagnostic breakthrough that will save time, resources and lives. This is welcome news for healthcare providers already under immense strain from COVID-19 and facing the added challenge of virulent influenza.

Quidel was the first company to develop an EUA cleared rapid point-of-care antigen test for COVID-19 and remains at the forefront of the battle against COVID-19. The company also developed the first flu test, the QuickVue® Influenza A/B Test, which received FDA approval in September of 1999. With the introduction of its ABC Test, Quidel has registered another first-of-its-kind innovation that packs both its flu and SARS diagnostic technologies onto one highly efficient test cartridge that can be manufactured on the same production lines now used for Sofia® SARS tests. By enabling three tests to be performed simultaneously on a single cartridge using a single swab sample, the company can scale seasonal production of flu tests without impacting its scheduled ramp of COVID-19 antigen test capacity.

While symptoms of flu and COVID are similar, JAMA reports that treatments are different. Even in non-pandemic years, influenza is a serious public health concern. According to a recent report in ScienceAdvances, the flu and other causes of pneumonia are the eighth leading cause of death in the United States.

Mr. Bryant added: “We believe that our new ABC Test (Sofia® 2 Flu + SARS Antigen FIA) will help reduce misdiagnosis, inform proper treatment and improve disease surveillance, significantly enhancing medical effectiveness in fighting COVID-19 and the flu,” Bryant concluded. “We are proud to put this powerful diagnostic tool in the hands of physicians and public health agencies at this critical time.”

Sofia® 2 is Quidel’s best-selling cartridge-based 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 in near real-time.

The Sofia® 2 instrument also offers two distinct workflows: depending upon the user’s choice, the Sofia® 2 SARS Antigen FIA cartridge is placed inside Sofia® 2 for automatically timed development (WALK AWAY Mode); or test cartridges can be placed on the counter or bench top for a manually timed development and then placed into Sofia® 2 to be scanned (READ NOW Mode), allowing the user to markedly increase testing throughput per hour.

The Sofia® 2 Flu + SARS Antigen FIA is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers. Quidel also offers the Sofia® SARS Antigen FIA under EUA as well as several other Sofia® assays, which are FDA cleared and CLIA waived, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 15-minute finger-stick whole blood test for Lyme Disease. In addition, Quidel also markets Sofia® tests for Lyme Disease, Legionella and S. pneumoniae in Europe.

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