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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version on businesswire.com: https://www.businesswire.com/news/home/20181129005440/en/
Quidel Contact:Quidel CorporationRandy StewardChief Financial
Officer(858) 552-7931
Media and Investors Contact:Quidel CorporationRuben Argueta(858)
646-8023rargueta@quidel.com
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