SAN DIEGO--(BUSINESS WIRE)--Nov. 29, 2018--
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a
provider of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that Quidel has
received CE Mark for its TriageTrueTM High Sensitivity
Troponin I Test for the quantitative determination of troponin I in EDTA
anticoagulated whole blood and plasma specimens. The test is to be used
as an aid in the diagnosis of myocardial infarction (MI) for use with
Quidel’s Triage® MeterPro instrumented system.
MI, or heart attack, occurs when a part of the heart muscle doesn’t
receive enough blood flow. The more time that passes without treatment
to restore blood flow, the greater the damage to the heart
muscle. According to the World Health Organization (WHO), it is
estimated that almost 18 million people die each year from
cardiovascular diseases (CVD), and 85% of all CVD deaths are due
to heart attacks and strokes.1
Troponin I, T and C are protein subunits that make up the troponin
complex, which is integral to the regulation of myofibril contraction in
skeletal and cardiac muscle cells. Cardiac troponin I assays are
commonly used as aids in the diagnosis of MI which is injury to cardiac
muscle cells caused by ischemia. When an MI occurs, cardiac troponin I
levels rise after the onset of cardiac symptoms, reaching a peak at 12
to 16 hours and can remain elevated for 4 to 9 days. Upon patient
presentation, the determination of presence and concentration of
troponin levels through serial monitoring at different time points can
help diagnose MI and differentiate it from other cardiovascular and
non-cardiovascular conditions.
The latest generation of troponin assays can detect and quantitate
troponin at lower levels than previous generation assays, giving them
higher sensitivity for the detection of MI at the time of patient
presentation. This advancement allows for the time interval between
baseline measurement and the second measurement of cardiac troponin to
be significantly shortened, thereby reducing the time to diagnosis and
improving efficiency in the emergency department.
The TriageTrueTM High Sensitivity Troponin I Test is a
single-use fluorescence immunoassay device for use with Quidel’s Triage®
MeterPro instrument and designed to determine the concentration of
troponin I in whole blood or plasma specimens, anticoagulated with EDTA.
TriageTrueTM features a redesigned cartridge that greatly
improves assay sensitivity and precision which are critical to the
performance of high sensitivity troponin testing. The assay uses
monoclonal antibodies specific to human cardiac troponin I in the
detection and quantitation of cardiac troponin I. The results are
displayed on the MeterPro screen in <20 minutes from the addition of
specimen to the device. All results are stored in the MeterPro memory to
display or print when needed. Also, the integrated cartridge design
enables a lower total cost per reportable result than standard
immunochemistry analyzers in low volume settings. When connected, the
MeterPro can transmit results to the laboratory or hospital information
system. TriageTrueTM enables hsTnI testing to be performed in
the emergency department, urgent care facilities and other decentralized
settings.
“We are very pleased to receive the CE Mark for our next-generation
Troponin I assay. This accomplishment is truly a team effort, and really
speaks to the success of our integration of our Triage team at Summers
Ridge,” said Douglas Bryant, president and chief executive officer
of Quidel Corporation. “We are proud to introduce the world’s first Near
Patient high sensitivity diagnostic test for Troponin I, and are excited
by the positive impact that we can make in accurately providing results
in 20 minutes or less to aid in diagnosing a heart attack.”
1. http://www.who.int/cardiovascular_diseases/en/
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, 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