Quidel is a California-based leading diagnostic manufacturer focused on improving the quality of healthcare throughout the globe. As a trusted innovator in the medical device industry for over 40 years, Quidel launched the QuickVue brand 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 cleared by the FDA for professional use. Now, the QuickVue At-Home COVID-19 Test* utilizes the same technology used for decades by healthcare professionals and makes simple, easy-to-use COVID-19 tests accessible for the good of our families, our communities, and the world.
CDC confirms 1st U.S. case from community spread in CA. White House Task Force created and led by VP Pence.
Quidel CEO and CFO invited to meet with White House Task Force to discuss testing. In less than 2 weeks, Quidel begins shipping their 1st EUA test for COVID-19. This was one of the first EUA’s to detect the virus in individuals suspected of having COVID-19.
Quidel receives its 1st EUA on Lyra, a molecular RT-PCR test to detect SARS-CoV-2 RNA in individuals suspected of having COVID-19. Quickly ramps up manufacturing capacity to 1 Million tests per month. A 3rd EUA was issued on May 18 for a direct PCR assay without extraction.
Quidel receives its 2nd EUA on the first rapid, 15-minute immuneassay test to detect SARS viral antigen (nucleocapsid protein) in individuals suspected of having COVID-19 on its flagship platform, Sofia 2. Quickly ramps up manufacturing capacity to 1.125 Million tests per week or 4.5 Million tests per month. Quidel receives approval on an EUA amendment on June 9, for the SARS Antigen test on the original Sofia analyzer. On July 17, Sofia SARS Antigen FIA updates performance data.
Quidel receives EUA for another first rapid, 15-minute immunoassay Multi-Antigen Respiratory Panel to differentiate Influenza A+B from COVID-19.
Quidel receives EUA for another rapid immunoassay, QuickVue, to detect SARS viral antigen nucleocapsid proteins using a simple test strip with no instrument. Direct anterior nares swab samples can be used.
Quidel receives EUA for a 25-minute molecular test to detect SARS-CoV-2 viral RNA in individuals suspected of having COVID-19 on its Solana platform. Quickly ramps up Solana manufacturing capacity to 750,000 tests per month.
Quidel receives EUA for QuickVue At-Home COVID-19 Test to detect SARS viral antigen nucleocapsid proteins using a simple strip with no instrument. Prescriptions only.
Quidel receives EUA for QuickVue At-Home OTC COVID-19 Test – No Prescription Required.
Quidel receives EUA for updated Solana SARS-CoV-2 Assay with Lyophilized Master Mix.