Quidel Receives CE Mark for Its Sofia(R) Legionella Fluorescent Immunoassay (FIA)
November 07 2012 - 6:15PM
Marketwired
Quidel Corporation (NASDAQ: QDEL), a leading
provider of diagnostic testing solutions and cellular-based
virology assays, announced today that it has received the CE Mark
for its Sofia Legionella FIA for use on the Sofia Analyzer for the
rapid detection of Legionnaires' disease, also known as
legionellosis.
The Gram-negative bacterium, Legionella pneumophila, is the
cause of this life-threatening respiratory illness. The symptoms of
Legionnaires' disease mimic those commonly associated with
influenza, including headache, fever, muscle pain, and chills in
the first day, but gradually expand to include cough and shortness
of breath by day three. If diagnosed early in the infection, this
disease can be effectively treated with antibiotics, but if left
untreated, the disease can be fatal, especially among elderly and
immunocompromised patients. In 2009, the European Center for
Disease Prevention and Control reported nearly 6,000 cases of
Legionnaires' disease, but stated that the actual number of cases
in Europe was likely significantly under-reported.(1) In the United
States, where the incidence of Legionnaires' disease has tripled in
the last decade, the disease accounts for nearly 8,000 to 18,000
hospitalizations per year.(2)
Sofia is the brand name for Quidel's next generation,
immunoassay system that was launched earlier this year. The Sofia
Analyzer and Sofia Legionella FIA combine unique immunofluorescence
chemistry, advanced lateral flow technology, and failure alert and
fail-safe systems designed to ensure a reliable, objective, highly
accurate, diagnostic result within ten (10) minutes of application
of the patient's specimen. The Sofia system was 510(k) cleared in
October of 2011, and its first test, the Sofia Influenza A+B FIA,
received Clinical Laboratory Improvement Amendments (CLIA) waiver
by the U.S. FDA in April of 2012.
The CE Mark allows Quidel to launch its new Sofia Legionella FIA
in Europe.
"We are extremely pleased to announce the CE Mark and impending
launch of our fourth Sofia assay in Europe," said Douglas Bryant,
president and chief executive officer of Quidel Corporation. "The
Sofia Legionella FIA will provide customers with an accurate,
ten-minute solution for the diagnosis of Legionnaires' disease.
Receiving the CE Mark is another milestone testifying to the
promise of the aggressive development program we instituted nearly
three years ago -- one achievement of which is the unique Sofia
immunofluorescence platform and system."
The Sofia Legionella assay uses the Sofia Analyzer, an
instrument that is designed to easily incorporate new
analyte-specific algorithms -- an important feature as the Sofia
menu of products expands. The other Sofia immunoassays presently
for sale in Europe include FIAs for Influenza A+B, Strep A and
RSV.
(1) Risk for Travel-associated Legionnaires' Disease, Europe,
2009 http://wwwnc.cdc.gov/eid/article/18/11/12-0496_article.htm#r6
(2) Patient Facts: Learn More about Legionnaires' disease
http://www.cdc.gov/legionella/patient_facts.htm
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
QuickVue®, D3® Direct Detection and Thyretain® leading brand names,
as well as under the new Sofia® brand, 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 research and development engine is also developing a
continuum of diagnostic solutions from advanced lateral-flow and
direct fluorescent antibody 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 and
Diagnostic Hybrids at dhiusa.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,
seasonality, the timing of onset, length and severity of cold and
flu seasons, the level of success in executing on our strategic
initiatives, our reliance on sales of our influenza diagnostic
tests, uncertainty surrounding the detection of novel influenza
viruses involving human specimens, our ability to develop new
products and technology, adverse changes in the competitive and
economic conditions in domestic and international markets, our
reliance on and actions of our major distributors, technological
changes and uncertainty with research and technology development,
including any molecular-based technology, the medical reimbursement
system currently in place and future changes to that system,
manufacturing and production delays or difficulties, adverse
actions or delays in product reviews by the U.S. Food and Drug
Administration (the "FDA"), our ability to comply with FDA,
environmental and other regulations, our ability to meet unexpected
increases in demand for our products, our ability to execute our
strategy, including the integration of new companies or
technologies, disruptions in the global capital and credit markets,
our ability to hire key personnel, intellectual property, product
liability, environmental or other litigation, potential required
patent license fee payments not currently reflected in our costs,
adverse changes in our international markets, potential inadequacy
of booked reserves and possible impairment of goodwill, and
lower-than-anticipated acceptance, sales or market penetration of
our new products. Forward-looking statements typically are
identified by the use of terms such as "may," "will," "should,"
"might," "expect," "anticipate," "estimate," and similar words,
although some forward-looking statements are expressed differently.
The risks described under "Risk Factors" in reports and
registration statements that we file with 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. We
undertake no obligation to publicly release the results of any
revision or update of the forward-looking statements, except as
required by law.
2247ID1112D (11/12)
Quidel Contact: Quidel Corporation Randy Steward Chief Financial
Officer (858) 552-7931 Media and Investors Contact: Quidel
Corporation Ruben Argueta (858) 646-8023 Email Contact
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