Quidel Receives Emergency Use Authorization for Molecular COVID-19 Diagnostic Assay
March 17 2020 - 8:30PM
Business Wire
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider
of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that
Quidel has received Emergency Use Authorization (EUA) from the U.S.
Food and Drug Administration (FDA) to market its Lyra® SARS-CoV-2
Assay, a real-time RT-PCR test intended for the qualitative
detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or
oropharyngeal swab specimens from patients suspected of COVID-19 by
their healthcare provider. Testing is limited to laboratories
certified under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
EUAs allow for the early availability of important diagnostic tools
“when there are no adequate, approved and available
alternatives.”1
The Lyra® product line offers PCR reagent kits for use by
molecular diagnostic laboratories with existing molecular testing
infrastructure such as the Applied Biosystems® 7500 Fast DX
instruments. These reagents include unique features that provide
for simple transport and storage, improved workflow, shorter time
to result, and other benefits that favorably affect diagnostic test
outcome. The Lyra SARS-CoV-2 Assay provides these and certain
additional advantages over other tests currently on the market for
this novel coronavirus, including easier setup and faster time to
result.
“Emergency Use Authorization for our Lyra® SARS-CoV-2 Assay
allows Quidel to join the global fight against the COVID-19
outbreak by providing healthcare workers in highly complex
laboratories with a fast, accurate tool to diagnose patients
infected with the novel coronavirus. The feature benefits of the
test system and the Lyra product will contribute substantially to
our country’s efforts to fight this pandemic,” said Douglas Bryant,
President and CEO of Quidel. “We are proud to have quickly
developed this assay in mere weeks, and to have manufactured kits,
several of which are in transit to customers. Anticipating
significant demand, we are allocating kits across a broad set of
customers as we ramp production.”
The Lyra® SARS-CoV-2 Assay is currently only available for sale
in the United States and can be purchased either through Quidel’s
salesforce or Cardinal Health.
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https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
About Quidel Corporation
Quidel Corporation serves to enhance the health and well-being
of people around the globe through the development of diagnostic
solutions that can lead to improved patient outcomes and provide
economic benefits to the healthcare system. Marketed under the
Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and
InflammaDry® leading brand names, as well as under the Solana®,
AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products
aid in the detection and diagnosis of many critical diseases and
conditions, including, among others, influenza, respiratory
syncytial virus, Strep A, herpes, pregnancy, thyroid disease and
fecal occult blood. Quidel's Triage® system of tests comprises a
comprehensive test menu that provides rapid, cost-effective
treatment decisions at the point-of-care (POC), offering a diverse
immunoassay menu in a variety of tests to provide diagnostic
answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I
and qualitative TOX Drug Screen. Quidel’s research and development
engine is also developing a continuum of diagnostic solutions from
advanced immunoassay to molecular diagnostic tests to further
improve the quality of healthcare in physicians’ offices and
hospital and reference laboratories. For more information about
Quidel’s comprehensive product portfolio, visit quidel.com.
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 financial 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,
fluctuations in our operating results resulting from the timing of
the onset, length and severity of cold and flu seasons,
seasonality, government and media attention focused on influenza
and the related potential impact on humans from novel influenza
viruses, adverse changes in competitive conditions, the
reimbursement system currently in place and future changes to that
system, changes in economic conditions in our domestic and
international markets, lower than anticipated market penetration of
our products, the quantity of our product in our distributors’
inventory or distribution channels, changes in the buying patterns
of our distributors, and changes in the healthcare market and
consolidation of our customer base; our development and protection
of proprietary technology rights; our development of new
technologies, products and markets; our reliance on sales of our
influenza diagnostic tests; our reliance on a limited number of key
distributors; our exposure to claims and litigation, including the
ongoing litigation between the Company and Beckman Coulter, Inc.;
intellectual property risks, including but not limited to,
infringement litigation; our need for additional funds to finance
our capital or operating needs; the financial soundness of our
customers and suppliers; acceptance of our products among
physicians and other healthcare providers; competition with other
providers of diagnostic products; adverse actions or delays in new
product reviews 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
or clearances; changes in government policies; costs of or our
failure to comply with government regulations in addition to FDA
regulations; compliance with government regulations relating to the
handling, storage and disposal of hazardous substances; third-party
reimbursement policies; our failure to comply with laws and
regulations relating to billing and payment for healthcare
services; our ability to meet demand for our products;
interruptions in our supply of raw materials; product defects;
business risks not covered by insurance; failures in our
information technology or storage systems; our exposure to
cyber-based attacks and security breaches; competition for and loss
of management and key personnel; international risks, including but
not limited to, compliance with multiple product registration
requirements, compliance with U.S. and foreign import/export laws,
tariffs, exposure to currency exchange fluctuations and foreign
currency exchange risk sharing arrangements, longer payment cycles,
lower selling prices and greater difficulty in collecting accounts
receivable, reduced protection of intellectual property rights,
political and economic instability, increased financial accounting
and reporting burdens. taxes, and diversion of lower priced
international products into U.S. markets; changes in tax rates and
exposure to additional tax liabilities or assessments; our ability
to manage our growth strategy and identify and integrate acquired
companies or technologies; risks relating to the acquisition and
integration of the Triage and BNP Businesses; that we may have to
write off goodwill relating to our acquisitions; the level of our
indebtedness and deferred payment obligations; our ability to
generate sufficient cash flow to meet our debt service and deferred
payment obligations; that we may incur additional indebtedness;
that the Senior Credit Facility is secured by substantially all of
our assets; the agreements for our indebtedness place operating and
financial restrictions on the Company; that an event of default
could trigger acceleration of our outstanding indebtedness;
increases in interest rate relating to our variable rate debt;
dilution resulting from future sales of our equity; volatility in
our stock price; provisions in our charter documents, Delaware law
and the indenture governing our Convertible Senior Notes that might
delay or impede stockholder actions with respect to business
combinations or similar transactions; and our intention of not
paying dividends. 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 (the “SEC”) from
time to time, should be carefully considered. 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 the results of 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/20200317005867/en/
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931
Media and Investors Contact: Quidel Corporation Ruben Argueta
(858) 646-8023 rargueta@quidel.com
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