Quidel Corporation (NASDAQ: QDEL), a provider of rapid
diagnostic testing solutions, cellular-based virology assays and
molecular diagnostic systems, announced today that it has received
510(k) clearance from the United States Food and Drug
Administration (FDA) for Quidel’s CLIA Waived QuickVue® Influenza
A+B assay for the rapid, differential detection of influenza types
A and B.
In a recent clinical study, Quidel’s QuickVue® Influenza A+B
test was shown to meet the FDA’s reclassification criteria for
Class II Rapid Influenza Diagnostic Tests and is available for sale
in the United States. The assay allows for the rapid, qualitative
detection of influenza type A and type B antigens directly in nasal
swab and nasopharyngeal swab specimens from symptomatic
patients.
“Influenza is a highly contagious, acute, viral infection of the
respiratory tract, and rapid diagnosis is critical to avoid
potentially serious complications. Recent CDC figures and
positivity rates from our Sofia analyzers suggest that this year’s
influenza season may be getting worse, not better, and has
surpassed the rate of every other year except the unusual pandemic
of 2009. Quidel’s QuickVue® Influenza A+B test identifies and
differentiates influenza type A and B in approximately 10 minutes
aiding in better patient management decisions for healthcare
professionals,” commented Douglas Bryant, president and chief
executive officer of Quidel Corporation.
The causative agents of the disease are immunologically diverse,
single-strand RNA viruses known as influenza viruses. There are
three types of influenza viruses: A, B, and C. Type A viruses are
the most prevalent and are associated with the most serious
epidemics. Type B viruses produce a disease that is generally
milder than that caused by type A. Type C viruses have never been
associated with a large epidemic of human disease. Both type A and
B viruses can circulate simultaneously, but usually one type is
dominant during a given season.1
1 Murphy, B.R., and R.G. Webster. Orthomyxoviruses, In: Fields
Virology, 3rd edition, B.N. Fields, D.M. Knipe, P.M. Howley, et al.
(eds.), Lippincott-Raven, Philadelphia. 1996, pp. 1397–1445.
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, herpes, pregnancy, thyroid
disease and fecal occult blood. Quidel's recently
acquired 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 you with 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.
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 seasonality,
the timing of the onset, length and severity of cold and flu
seasons, government and media attention focused on influenza and
the related potential impact on humans from novel influenza
viruses, adverse changes in competitive conditions in domestic and
international markets, changes in sales levels as it relates to the
absorption of our fixed costs, lower than anticipated market
penetration of our products, the reimbursement system currently in
place and future changes to that system, changes in economic
conditions in our domestic and international markets, 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 intellectual property; our
development of new technologies, products and markets; our reliance
on a limited number of key distributors; our reliance on sales of
our influenza diagnostics tests; our ability to manage our growth
strategy; our ability to integrate companies or technologies we
have acquired or may acquire, including integration and transition
risks, the ability to achieve anticipated financial results and
synergies, and effects of disruptions or threatened disruptions to
our relationships, or those of the acquired businesses, with
distributors, suppliers, customers and employees; intellectual
property risks, including but not limited to, infringement
litigation; our debt service requirements; our inability to settle
conversions of our Convertible Senior Notes in cash; the effect on
our operating results from the trigger of the conditional
conversion feature of our Convertible Senior Notes; the possibility
that we may incur additional indebtedness; our need for additional
funds to finance our operating needs; volatility and disruption in
the global capital and credit markets; 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 FDA or any loss of previously received regulatory
approvals or clearances; changes in government policies; compliance
with other government regulations, such as safe working conditions,
manufacturing practices, environmental protection, fire hazard and
disposal of hazardous substances; third-party reimbursement
policies; our ability to meet demand for our products;
interruptions in our supply of raw materials; product defects;
business risks not covered by insurance and exposure to other
litigation claims; interruption to our computer systems;
competition for and loss of management and key personnel;
international risks, including but not limited to, compliance with
product registration requirements, 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, taxes, and diversion of lower priced international
products into U.S. markets; dilution resulting from future sales of
our equity; volatility in our stock price; provisions in our
charter documents, Delaware law and 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: http://www.businesswire.com/news/home/20180213006702/en/
Quidel CorporationQuidel Contact:Randy Steward, (858)
552-7931Chief Financial OfficerorMedia and Investors Contact:Ruben
Argueta, (858) 646-8023rargueta@quidel.com
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