Quidel’s Lyra® Direct SARS-CoV-2 Assay Receives Emergency Use Authorization & CE Mark for Molecular Detection of COVID-19,...
May 18 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) for the Lyra®
Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA)
to allow direct sample processing.
Lyra® Direct Removes RNA Extraction Processing Step, Removes
Supply Bottleneck
Under the new EUA, the Lyra® Direct SARS-CoV-2 Assay no longer
requires an up-front sample extraction. The Lyra® Direct SARS-CoV-2
Assay uses a reformulated buffer that replaces the extraction step
with a simple 10-minute heat step, saving approximately 50 minutes
in processing time. The assay retains its versatility in that it is
capable of running on any of seven possible thermocyclers (Applied
Biosystems 7500 Standard®, Applied Biosystems 7500 Fast®, Bio-Rad
CFX96 Touch®, Qiagen Rotor-Gene Q®, Roche LightCycler® 480, Roche
Cobas® z480, and Thermo Fisher QuantStudio 7 Pro®).1
Lyra® Direct Receives CE Mark
Separately, the Lyra® Direct SARS-CoV-2 Assay received CE Mark
on May 8, 2020. The CE Mark allows Quidel to market and sell the
Lyra® Direct SARS-CoV-2 Assay in Europe, as well as other countries
that accept the CE Mark.
The assay is currently available for sale in the United States
under EUA. The Lyra® Direct SARS-CoV-2 Assay can be purchased by
laboratory professionals through Quidel directly, or through their
Cardinal Health representative.
- Applied Biosystems®, CFX96 Touch®, Rotor-Gene Q®, LightCycler®
480, Cobas z480, and QuantStudio 7 Pro® are registered trademarks
of their respective owners.
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 new 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, lyme, 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 other respiratory viruses and the related potential impact on
humans from such novel influenza or other respiratory 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/20200518005776/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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