Quidel’s Sofia® SARS Antigen Test Receives Emergency Use Authorization for Screening Use With Serial Testing
April 01 2021 - 8:02PM
Business Wire
Easy-to-use test that provides results in 15
minutes is now available without a prescription
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading
provider of rapid diagnostic testing solutions, cellular-based
virology assays and molecular diagnostic systems, announced today
that it has received an Emergency Use Authorization (EUA) from the
U.S. Food and Drug Administration (FDA), allowing the company to
market its Sofia® SARS Antigen FIA for the qualitative
detection of the nucleocapsid protein antigen from SARS-CoV-2 from
anterior nares swab specimens directly from individuals who are
either suspected of COVID-19 by their healthcare provider within
the first five days of the onset of symptoms, or are individuals
without symptoms or other epidemiological reasons to suspect
COVID-19 tested twice over two (or three) days with at least 24
hours (and no more than 36 hours) between tests. Testing is limited
to laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the
requirements to perform moderate, high or waived complexity tests.
This test is authorized for use at the Point of Care (POC), i.e.,
in patient care settings operating under a CLIA Certificate of
Waiver, Certificate of Compliance, or Certificate of
Accreditation.
The Sofia® SARS Antigen FIA shows excellent performance within
the first five days of the onset of symptoms, with positive results
agreeing with PCR 96.7% of the time, and negative results agreeing
100% of the time, delivering confidence to physicians, healthcare
workers and other customers within the professional segment. This
new intended use allows the Sofia® SARS Antigen FIA to be used
among asymptomatic individuals and run without a prescription
provided that individuals test twice within 24-36 hours. Routine
testing by rapid antigen tests has shown to be effective in
diagnosing COVID-19.1 As with all antigen tests, performance may
decrease as days since symptom onset increases due to lower viral
loads later in the patient’s disease course. Similarly, the
inability to synchronize asymptomatic individuals with onset of
infection may impact performance as specimens may be tested when
viral loads are below the assay’s limit of detection. Clinical
studies in asymptomatic patients undergoing serial testing are
ongoing to establish the clinical performance.
“Quidel’s goal throughout this pandemic has been to develop the
most innovative and sensitive testing technologies on the market
and to make our COVID-19 tests as widely available as possible,”
said Douglas Bryant, president and CEO of Quidel Corporation.
“FDA’s authorization opens the door to true democratization of the
benefits of serial testing for both individuals experiencing
symptoms and screening of people who may not have symptoms but are
actively shedding the virus. Broadscale application of our Sofia®
rapid antigen test for COVID-19 screening will catch asymptomatic
cases early and limit virus spread.”
The Sofia® SARS Antigen FIA is only for use under the Food and
Drug Administration’s Emergency Use Authorization. The Sofia® SARS
Antigen FIA has not been FDA cleared or approved. The test has been
authorized only for the detection of proteins from SARS-CoV-2, not
for any other viruses or pathogens, and is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostic tests for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §
360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
-
https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2
About Quidel Corporation
Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of
diagnostic solutions at the point of care, delivering a continuum
of rapid testing technologies that further improve the quality of
health care throughout the globe. An innovator for over 40 years in
the medical device industry, Quidel pioneered the first FDA-cleared
point-of-care test for influenza in 1999 and was the first to
market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted
brand names Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’s
comprehensive product portfolio includes tests for a wide range of
infectious diseases, cardiac and autoimmune biomarkers, as well as
a host of products to detect COVID-19. With products made in
America, Quidel’s mission is to provide patients with immediate and
frequent access to highly accurate, affordable testing for the good
of our families, our communities and the world. For more
information about Quidel, visit quidel.com.
View our story told by our people at
www.quidel.com/ourstory.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the federal securities laws that involve material
risks, assumptions and uncertainties. Many possible events or
factors could affect our future results and performance, such that
our actual results and performance may differ materially from those
that may be described or implied in the forward-looking statements.
As such, no forward-looking statement can be guaranteed.
Differences in actual results and performance may arise as a result
of a number of factors including, without limitation: the impact
and duration of the COVID-19 global pandemic; competition from
other providers of diagnostic products; our ability to accurately
forecast demand for our products and products in development,
including in new market segments; our ability to develop new
technologies, products and markets and to commercialize new
products; our reliance on sales of our COVID-19 and influenza
diagnostic tests; our reliance on a limited number of key
distributors; quantity of our product in our distributors’
inventory or distribution channels; changes in the buying patterns
of our distributors; the financial soundness of our customers and
suppliers; lower than anticipated market penetration of our
products; third-party reimbursement policies and potential cost
constraints; our ability to meet demand for our products;
interruptions, delays or shortages in the supply of raw materials,
components and other products and services; failures in our
information technology and storage systems; our exposure to data
corruption, cyber-based attacks, security breaches and privacy
violations; international risks, including but not limited to,
economic, political and regulatory risks; continuing worldwide
political and social uncertainty; our development, acquisition and
protection of proprietary technology rights; intellectual property
risks, including but not limited to, infringement litigation; the
loss of Emergency Use Authorizations for our COVID-19 products and
failures or delays in receipt of reviews or regulatory approvals,
clearances or authorizations for new products or related to
currently-marketed products by the U.S. Food and Drug
Administration (the “FDA”) or other regulatory authorities or loss
of any previously received regulatory approvals, clearances or
authorizations or other adverse actions by regulatory authorities;
our contracts with government entities involve future funding,
compliance and possible sanctions risks; product defects; changes
in government policies and regulations and compliance risks related
thereto; our ability to manage our growth strategy and successfully
identify, acquire and integrate potential acquisition targets or
technologies and our ability to obtain financing; our acquisition
of Alere’s Triage® business presents certain risks to our business
and operations; the level of our deferred payment obligations; our
exposure to claims and litigation that could result in significant
expenses and could ultimately result in an unfavorable outcome for
us, including the ongoing litigation between us and Beckman
Coulter, Inc.; we may need to raise additional funds to finance our
future capital or operating needs; our debt, deferred and
contingent payment obligations; competition for and loss of
management and key personnel; business risks not covered by
insurance; changes in tax rates and exposure to additional tax
liabilities or assessments; and provisions in our charter documents
and Delaware law that might delay or impede stockholder actions
with respect to business combinations or similar transactions.
Forward-looking statements typically are identified by the use of
terms such as “may,” “will,” “should,” “might,” “expect,”
“anticipate,” “estimate,” “plan,” “intend,” “goal,” “project,”
“strategy,” “future,” and similar words, although some
forward-looking statements are expressed differently. The risks
described in reports and registration statements that we file with
the Securities and Exchange Commission from time to time, should be
carefully considered, including those discussed in Item 1A, “Risk
Factors” and elsewhere in our Annual Report on Form 10 K for the
year ended December 31, 2020 and in our subsequent Quarterly
Reports on Form 10 Q. You are cautioned not to place undue reliance
on these forward-looking statements, which reflect management’s
analysis only as of the date of this press release. Except as
required by law, we undertake no obligation to publicly release any
revision or update of these forward-looking statements, whether as
a result of new information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210401005968/en/
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931
Investors Contact: Quidel Corporation Ruben Argueta (858)
646-8023 rargueta@quidel.com
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