QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test

Original from: QuidelOrtho

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho" or the “Company”) has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its QuickVue COVID-19 test. This clearance allows the test to be used with accuracy and convenience in home and medical facility settings with CLIA certificates of waiver. This achievement also reflects QuidelOrtho’s dedication to delivering effective testing solutions while highlighting ongoing efforts in research and development to enhance market competitiveness.

Designed for symptomatic individuals within six days of symptom onset, the QuickVue COVID-19 test is cleared for use in individuals aged 14 or older when self-testing, and in those aged two and older when administered by an adult. 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. This clearance authorizes 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. As a result, upon reviewing the performance of the Savanna RVP4+ assay against the clinical market’s expectations, a decision was made to withdraw the current FDA 510(k) submission for the Savanna RVP4+ assay. Data generated over a 9-month period for the four viruses targeted by the assay initially showed great promise, which led to the FDA submission in July 2023. However, the final dataset, submitted in February 2024, did not meet our expectations. In addition, during the pendency of the submission, the Company has continued to develop the next-generation RVP4+ assay. The Company anticipates the new multiplex assay to be commercially available during the 2024/2025 respiratory season.

QuidelOrtho remains committed to expanding the Savanna platform menu. The Company is making good progress on a sexually transmitted infection (“STI”) panel and expects to begin clinical trials later in the second quarter.​

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Source: QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test