Quidel Corporation (NASDAQ: QDEL) (“Quidel”), 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) to market its Sofia Lyme FIA for the rapid
differential detection of human IgM and IgG antibodies to Borrelia
burgdorferi from serum and plasma specimens from patients suspected
of B. burgdorferi infection. The test is intended for use with the
Sofia analyzer to aid in the diagnosis of Lyme disease.
“With the clearance of the Sofia Lyme FIA, we are now able to
detect the microorganism associated with Lyme disease more rapidly
in near patient settings. This is another example of our ability to
provide simple, cost-effective solutions for physician offices and
hospitals that previously had to wait several days for send-out
Lyme results,” said Douglas Bryant, president and chief executive
officer of Quidel Corporation.
Lyme disease is the most common tickborne disease in North
America and Europe1. In the United States, Lyme disease is caused
by the bacterium, Borrelia burgdorferi, transmitted through the
bite of an infected blacklegged tick1,2.
Patients infected with B. burgdorferi may experience symptoms
associated with three stages: early localized disease, early
disseminated disease, and late persistent disease1. The most
characteristic symptom of early localized disease is the appearance
of erythema migrans (EM) on the skin1,3. EM may also be accompanied
by flu-like symptoms days or weeks after infection3. In the second
stage, early disseminated disease, untreated patients may begin to
see neurological and rheumatological manifestations, and less
commonly, dermatological, cardiac, or ophthalmological
manifestations. These symptoms generally appear weeks to months
after infection1. If the disease continues to be left untreated,
late persistent disease may also follow months or years later with
continued progression of manifestations in the joints, heart, skin,
and nervous system2,3.
Early detection and treatment of Lyme disease can help resolve
symptoms and prevent progression of the disease1. The primary means
of identifying B. burgdorferi infection is detection of the body’s
IgM and IgG antibody response by way of immunoassay3. Detection of
IgM antibodies to B. burgdorferi is generally most significant in
the earlier stages of the disease. Conversely, detection of IgG
antibodies has proven to be significant for longer periods, as the
antibodies may remain detectable years after infection.
The Sofia analyzer and Sofia Lyme FIA combine unique
immunofluorescence chemistry, advanced lateral flow technology, and
failure alert and fail-safe systems designed to ensure reliable,
objective, diagnostic results within 10 minutes of application of
the patient's specimen. The Sofia Lyme FIA is the first to provide
differentiated results for both IgM and IgG on a single test.
____________________________________________________________________________________
1) Wormser, G. P., Dattwyler, R. J., Shapiro,
E. D., Halperin, J. J., Steere, A. C., Klempner, M. S., Nadelman,
R. B. (2006). The Clinical Assessment, Treatment, and Prevention of
Lyme Disease, Human Granulocytic Anaplasmosis, and Babesiosis:
Clinical Practice Guidelines by the Infectious Diseases Society of
America. Clinical Infectious Diseases, 43(9), 1089-1134. 2)
CDC.
http://www.cdc.gov/lyme/diagnosistesting/LabTest/TwoStep/index
3) Aguero-Rosenfeld, M. E., Wang, G., Schwartz, I., & Wormser,
G. P. (2005). Diagnosis of Lyme Borreliosis. Clinical Microbiology
Reviews, 18(3), 484-509.
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.
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 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/20171023005400/en/
Quidel CorporationRandy Steward, 858-552-7931Chief Financial
OfficerorAngie Mazza, 312-690-6006amazza@clermontpartners.com
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