QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test
- QuidelOrtho receives FDA 510(k) clearance for QuickVue COVID-19 test
- QuickVue COVID-19 test can be used at home and in medical facilities
- Clearance allows use in symptomatic individuals aged 14 and older
- QuidelOrtho withdraws FDA submission for Savanna RVP4+ assay
- Anticipates new multiplex assay release in 2024/2025 respiratory season
- Data for Savanna RVP4+ assay did not meet expectations
- Submission for Savanna RVP4+ assay withdrawn
Insights
The FDA 510(k) clearance of QuidelOrtho's QuickVue COVID-19 test for home and medical facility use represents a significant milestone in the diagnostic testing market. This event is poised to influence the company's market share and competitive edge in the industry. The ability to offer a rapid, 10-minute testing solution that caters to a broad age range enhances QuidelOrtho's product portfolio and addresses a persistent need for convenient testing options.
Furthermore, the withdrawal of the FDA 510(k) submission for the Savanna RVP4+ assay indicates a strategic pivot based on data-driven decisions. This reflects a commitment to quality and reliability, which can strengthen customer trust and brand reputation. The anticipated launch of the next-generation RVP4+ assay during the 2024/2025 respiratory season, along with progress on an STI panel, suggests a forward-looking approach to R&D, with potential to capture emerging market opportunities as diagnostic needs evolve.
The clearance of the QuickVue COVID-19 test aligns with the ongoing demand for accessible and reliable diagnostics. The test's design for symptomatic individuals and the requirement for re-testing in case of a negative result underscore the importance of sensitivity and specificity in diagnostic tools. These factors are critical in maintaining public health standards and ensuring accurate patient care.
On the other hand, the retraction of the Savanna RVP4+ assay's submission highlights the rigorous standards upheld by QuidelOrtho and the FDA. The decision to focus on the development of a next-generation assay may delay immediate revenue streams but suggests a long-term strategy to deliver superior diagnostic solutions. This approach could foster innovation and potentially lead to more effective management of respiratory illnesses in the future.
The FDA clearance for the QuickVue test could translate into increased sales and market penetration for QuidelOrtho, especially considering the broad authorization for home and medical facility use. However, the financial impact of withdrawing the Savanna RVP4+ assay's FDA submission may introduce volatility in the company's stock performance, as investors reassess the company's R&D efficacy and pipeline robustness.
Investors will also be monitoring the development of the next-generation RVP4+ assay and the STI panel, as these products could represent significant future revenue streams. The timing of clinical trials and commercial availability of these assays will be key in evaluating the company's growth trajectory and its ability to capitalize on market trends in the diagnostics sector.
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 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
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.
For more information, please visit www.quidelortho.com.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240401748874/en/
Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com
Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com
Source: QuidelOrtho Corporation
FAQ
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