SAN DIEGO--(BUSINESS WIRE)--Dec. 18, 2018--
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 CE
Mark to market Quidel’s Sofia 2 Lyme+ FIA to be used with the Sofia 2
Fluorescent Immunoassay Analyzer for the rapid differential detection of
human IgM and IgG antibodies to Borrelia burgdorferi, Borrelia
garinii, and Borrelia afzelii from serum and plasma
specimens. The test is specifically developed for the European market
and intended for use with the Sofia 2 analyzer to aid in the diagnosis
of Lyme disease.
Sofia 2 is Quidel’s next-generation version of its best-selling Sofia
instrumented system. Sofia 2 utilizes the original Sofia’s fluorescent
chemistry design while improving upon the graphical user interface and
optics system to provide an accurate, automated and objective result in
as few as 3 minutes. Sofia 2 also integrates ethernet connectivity and
its barcode scanner within a smaller footprint than the legacy Sofia
instrument.
Lyme disease (LD) is the most common tickborne disease in North America
and Europe.1 While Lyme disease is caused by the Borrelia
burgdorferi bacterium in the U.S., Borrelia afzelii and Borrelia
garinii are the major pathogenic species found in Europe,
transmitted through the bite of an infected tick.1,2 Patients
infected with B. burgdorferi, B. afzelii, and/or B.
garinii may experience symptoms associated with three stages: early
localized disease, early disseminated disease, and late persistent
disease.1 The most characteristic symptom of early localized
disease is the appearance of erythema migrants (EM) on the skin, which
appears in up to 80% of cases.1,4 EM may also be accompanied
by flu-like symptoms (headache, abdominal pain, and fatigue) days or
weeks after infection.4 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 infection.1 If the disease
continues to be left untreated, late persistent disease may also follow
months or years later.4 In late stage disease, patients may
see continued progression of manifestations in the joints, heart, skin,
and nervous system.2
Early detection and treatment of LD can help resolve symptoms and
prevent progression of the disease.1 The primary means of
identifying B. burgdorferi, B. afzelii, and B. garinii infection
is detection of the body’s IgM and IgG antibody response using
immunoassay. Detection of IgM antibodies to B. burgdorferi, B.
afzelii, and B. garinii 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.4
“With the addition of the antigens specific to the predominant Borrelia
strains in Europe, the Sofia 2 Lyme+ assay’s CE mark for use on the
Sofia 2 instrument will allow healthcare workers to generate an
accurate, faster result, thereby accelerating the diagnosis and
potential treatment of Lyme Disease for the patient. 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. “We expect that this new
product introduction will increase the value and utilization of our
Sofia 2 platform in Europe and could create incremental instrument
placement opportunities in the near to medium term.”
Quidel also markets other Sofia immunoassays in the EU to aid in the
diagnosis of infections such as Influenza A+B, Respiratory Syncytial
Virus (RSV), Group A Streptococcus, Legionella, and S. pneumoniae.
_________________________________________________________________
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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.
-
Stanek, G., Strle, F. (2008). Lyme Disease – European Perspective.
Infectious Disease Clinics of North America, 22(2), 327-339.
-
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 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, a final determination that some of the
provisions of our contractual arrangement with Beckman Coulter are
unenforceable or otherwise not valid; our reliance on sales of our
influenza diagnostic tests; 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 the related potential impact on humans from novel
influenza viruses, adverse changes in competitive conditions in domestic
and international markets, 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 a limited number of key
distributors; 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; our exposure to claims and litigation, including litigation
currently pending against us; 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; 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 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;
changes in tax rates and exposure to additional tax liabilities or
assessments; risks relating to the acquisition and integration of the
Triage and BNP Businesses; Alere’s failure to perform under various
transition agreements relating to our acquisition of the Triage and BNP
Businesses; that we may incur substantial costs to build our information
technology infrastructure to transition the Triage and BNP Businesses;
that we may have to write off goodwill relating to our acquisition of
the Triage and BNP Businesses; that we our ability to manage our growth
strategy; the level of our indebtedness; the amount of, and our ability
to repay, renew or extend, our outstanding debt and its impact on our
operations and our ability to obtain financing; that substantially the
Senior Credit Facility is secured by substantially all of our assets;
our prepayment requirements under the Senior Credit Facility; 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; 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; that we may incur additional
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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Source: Quidel Corporation
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