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

Test Delivers on Company Commitment to Advance the Power of Diagnostics to Empower Patients with Rapid Results in Just 10 Minutes

Savanna® RVP4+ Assay Research and Development Update

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.

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QuidelOrtho QuickVue COVID-19 Test (Photo: Business Wire)

QuidelOrtho QuickVue COVID-19 Test (Photo: Business Wire)

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.

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.

Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.

QuidelOrtho is advancing diagnostics to power a healthier future.

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Source: QuidelOrtho Corporation

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho’s expectations regarding development and regulatory timelines for the Savanna RVP4+ assay and the STI panel, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue” or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho’s management as of today and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results to differ from those set forth or implied in the forward-looking statements: geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those discussed under Part I, Item 1A, “Risk Factors” of QuidelOrtho’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and subsequent reports filed with the Securities and Exchange Commission. You should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date hereof. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.


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