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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version on businesswire.com: https://www.businesswire.com/news/home/20181213005920/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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