FDA Clears QuidelOrtho’s COVID-19 Test

QuidelOrtho Corporation has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its QuickVue COVID-19 test.

The clearance allows the test to be used at home and/or in medical facilities. Designed for symptomatic individuals within six days of symptom onset, the QuickVue COVID-19 test can screen for the virus in those ages 2 and older. Symptomatic individuals receiving an initial negative result must undergo re-testing between 48 and 72 hours later, using either an antigen or molecular test for SARS-CoV-2. For healthcare providers, comprehensive instructions for use accompany the QuickVue COVID-19 test, facilitating seamless integration into existing diagnostic protocols.

QuidelOrtho secured FDA 510(k) clearance in December 2023 for its Savanna PCR platform and Savanna HSV 1+2/VZV PCR assay. That clearance authorized the marketing and sale of the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to U.S. laboratories conducting moderate or high complexity diagnostic testing. QuidelOrtho is committed to building the Savanna menu with the highest quality assays. However, upon reviewing the Savanna RVP4+ assay’s performance against the clinical market’s expectations, the company decided to withdraw the current FDA 510(k) submission. Data generated over a nine-month period for the four viruses targeted by the assay initially showed great promise, which led to the FDA submission last summer but the final dataset submitted in February 2024 fell short of expectations. In addition, during the pending submission, QuidelOrtho continued to develop the next-generation RVP4+ assay.

QuidelOrtho anticipates the new multiplex assay to be commercially available during the 2024/2025 respiratory season.

QuidelOrtho develops in-vitro diagnostics solutions that transform data into understanding and action. The company offers expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing diagnostics when and where they are needed – from home to hospital, lab to clinic. QuidelOrtho partners with customers worldwide across the healthcare continuum to forge a new diagnostic frontier.