QuidelOrtho Receives FDA 510(k) Clearance for Its QuickVue® COVID-19 Test
April 02 2024 - 9:00AM
Business Wire
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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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the full release here:
https://www.businesswire.com/news/home/20240401748874/en/
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.
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
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