SAN DIEGO--(BUSINESS WIRE)--Feb. 13, 2018--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180213006702/en/
Source: Quidel Corporation
Quidel Corporation
Quidel Contact:
Randy Steward, (858)
552-7931
Chief Financial Officer
or
Media and Investors
Contact:
Ruben Argueta, (858) 646-8023
rargueta@quidel.com