Company Website:
http://www.quidel.com
SAN DIEGO -- (Business Wire)
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a
provider of rapid diagnostic testing solutions, cellular-based virology
assays and molecular diagnostic systems, announced today that the
manufacturing of Quidel Triage® PLGF Test is set to resume in
2019 and be commercially available outside the US for clinical use in Q1
2019. Knowledge of maternal circulating concentration of Placental
Growth Factor (PLGF), a biomarker for placental dysfunction, aids in the
early and accurate diagnosis of preterm pre-eclampsia and helps
clinicians to accurately risk-stratify pregnant women resulting in more
efficient use of healthcare resources and the potential for cost-saving
to the healthcare system.
In Quidel’s acquisition of the Triage® business from Alere
Inc., ownership of the Triage PLGF product, together with the continued
supply of product into key clinical studies, transferred to Quidel.
Quidel has completed an internal review of unmet clinical needs in the
management of pre-eclampsia and the strength of clinical evidence and
has concluded that Quidel Triage PLGF Test is a competitive and
medically necessary diagnostic test.
Current antenatal detection of pre-eclampsia relies on clinical markers,
blood pressure and urinalysis for protein, which have low sensitivity
and specificity, and poor prognostic ability. A low PLGF concentration
in the maternal circulation identifies pregnancies likely to develop
placentally-driven complications, such as preterm pre-eclampsia and
fetal growth restriction. In May 2016, the UK National Institute for
Health and Care Excellence (NICE) developed a national guidance for NHS
England on PLGF-based testing1 to help clinicians diagnose
pre-eclampsia in women suspected of having the condition. NICE
recommends the use of PLGF-based tests, including Triage PLGF, to help
rule-out pre-eclampsia in pregnant women who are between 20 weeks and 34
weeks plus 6 days’ gestation and have signs or symptoms of pre-eclampsia.
Uniquely, Quidel’s PLGF measurements are performed on the Quidel Triage
MeterPro, a small low-cost benchtop analyzer that enables near patient
testing and provides results in about 15 minutes. Quidel Triage MeterPro
can connect to laboratory information systems and has built-in quality
control features. Quidel’s MeterPro platform offers end-users a more
cost-efficient and expedient testing platform than central laboratory
analyzers.
“We are happy to re-introduce Quidel Triage PLGF into the marketplace,
thereby assisting healthcare workers in ruling out pre-eclampsia, and
protecting our most vulnerable patients,” said Douglas Bryant, president
and chief executive officer of Quidel Corporation. “Longer term, we
believe that clinicians will find that the test has additional clinical
value in evaluating placental health.”
Quidel’s Triage PLGF product is currently CE Marked, and only available
for sale outside the United States.
1 PLGF-based testing to help diagnose suspected pre-eclampsia
(Triage PLGF test, Elecsys immunoassay sFlt-1/PLGF ratio, DELFIA Xpress
PLGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE
ratio). National Institute for Health and Care Excellence (NICE)
Diagnostics guidance [DG23] Published date: May 2016.
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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Contacts:
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
Source: Quidel Corporation
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