LabCorp joins QIAGEN’s “Day-One” program designed to help deliver
precision medicine to patients faster
HILDEN, Germany & GERMANTOWN, Md.–(BUSINESS WIRE)—-QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
a master service agreement with LabCorp® (NYSE: LH) to
further accelerate the access of cancer patients to QIAGEN’s companion
diagnostic products following regulatory approvals of drugs and their
associated tests.
As a new participant in QIAGEN’s Day-One Lab Readiness program, LabCorp
will be able to provide physicians and patients with faster access to
new, genomically targeted drugs that are becoming increasingly important
therapies for a growing variety of cancers. LabCorp is the latest
company to join the program, and its expertise in the commercial use of
companion diagnostics will help a broader range of patients gain access
to innovative tools for precision medicine.
Building on the U.S. Food and Drug Administration’s modernized
regulatory approach, QIAGEN´s Day-One Lab Readiness program enables
molecular diagnostic labs to begin implementing the activities necessary
to prepare for commercial launch of new drugs and IVD tests once FDA
approval is obtained.
LabCorp’s participation in QIAGEN´s network of laboratory partners will
contribute to ensuring testing readiness for a portfolio of new
companion diagnostics, including tests based on next generation
sequencing (NGS) and qualitative polymerase chain reaction (qPCR), being
prepared for launches in 2019 and 2020 in several countries around the
world.
As more biomarkers and new technologies are used to develop in vitro
diagnostics (IVD), companion diagnostic testing is becoming increasingly
complex. LabCorp’s extensive experience in these areas is a strong
complement to QIAGEN’s personalized health collaborations with leading
pharmaceutical companies. Assays for multiple indications, including
novel companion diagnostics across a range of cancers including lung,
breast, colorectal, bladder and eventually pan-tumor disease areas, are
currently in LabCorp’s Day-One Lab Readiness pipeline.
“Our Day-One Lab Readiness program covers all the steps in being able to
begin serving patients with access to companion diagnostic results
immediately upon approval of new targeted therapies and the related
companion diagnostics. Our Day-One program includes pre-approval
preparation of workflow implementation, training, assay verification,
forecasting, medical communication and reimbursement to ensure immediate
readiness,” said Thierry Bernard, Senior Vice President and Head of
QIAGEN’s Molecular Diagnostics Business Area. “LabCorp has a broad
global presence and deep involvement in clinical testing, and we have a
long history of working together. Day-One Readiness marks a new level of
our successful collaboration with LabCorp, which already ensures patient
access to several precision diagnostic tests, including therascreen®
assays for oncology and also NGS solutions. By aligning the timelines of
LabCorp and our partners, we can bring new treatment options to market
earlier.”
“LabCorp’s expanded collaboration with QIAGEN builds on our leading
position in companion diagnostics, and it allows us to make those
precision tests and new targeted drugs available sooner to physicians
and patients,” said Marcia Eisenberg, Ph.D., Chief Scientific Officer of
LabCorp Diagnostics. “This is perfectly aligned with LabCorp’s mission
to improve health and improve lives by delivering world-class
diagnostics, bringing innovative medicines to patients faster, and using
technology to improve the delivery of care. LabCorp Diagnostics and our
Covance Drug Development business already work closely with QIAGEN and
its pharma partners on multiple oncology biomarker and clinical trial
programs, and we are pleased to join the Day-One Lab Readiness program.”
About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global
provider of Sample to Insight solutions that enable customers to gain
valuable molecular insights from samples containing the building blocks
of life. Our sample technologies isolate and process DNA, RNA and
proteins from blood, tissue and other materials. Assay technologies make
these biomolecules visible and ready for analysis. Bioinformatics
software and knowledge bases interpret data to report relevant,
actionable insights. Automation solutions tie these together in seamless
and cost-effective workflows. QIAGEN provides solutions to more than
500,000 customers around the world in Molecular Diagnostics (human
healthcare), Applied Testing (primarily forensics), Pharma (pharma and
biotech companies) and Academia (life sciences research). As of December
31, 2018, QIAGEN employed about 5,000 people in over 35 locations
worldwide. Further information can be found at http://www.qiagen.com.
About LabCorp
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life
sciences company that is deeply integrated in guiding patient care,
providing comprehensive clinical laboratory and end-to-end drug
development services. With a mission to improve health and improve
lives, LabCorp delivers world-class diagnostic solutions, brings
innovative medicines to patients faster, and uses technology to improve
the delivery of care. LabCorp reported net revenues of more than $11
billion for in 2018. To learn more about LabCorp, visit www.LabCorp.com,
and to learn more about Covance Drug Development, visit www.Covance.com.
QIAGEN Forward-Looking Statement
Certain statements contained in this press release may be considered
forward-looking statements within the meaning of Section 27A of the U.S.
Securities Act of 1933, as amended, and Section 21E of the U.S.
Securities Exchange Act of 1934, as amended. To the extent that any of
the statements contained herein relating to QIAGEN’s products, launches,
regulatory submissions, collaborations, markets, strategy, taxes or
operating results, including without limitation its expected sales,
adjusted net sales and adjusted diluted earnings per share results, are
forward-looking, such statements are based on current expectations and
assumptions that involve a number of uncertainties and risks. Such
uncertainties and risks include, but are not limited to, risks
associated with management of growth and international operations
(including the effects of currency fluctuations, regulatory processes
and dependence on logistics); variability of operating results and
allocations between customer classes; the commercial development of
markets for our products to customers in academia, pharma, applied
testing and molecular diagnostics; changing relationships with
customers, suppliers and strategic partners; competition; rapid or
unexpected changes in technologies; fluctuations in demand for QIAGEN’s
products (including fluctuations due to general economic conditions, the
level and timing of customers’ funding, budgets and other factors); our
ability to obtain regulatory approval of our products; difficulties in
successfully adapting QIAGEN’s products to integrated solutions and
producing such products; the ability of QIAGEN to identify and develop
new products and to differentiate and protect our products from
competitors’ products; market acceptance of QIAGEN’s new products and
the integration of acquired technologies and businesses; and the other
factors discussed under the heading “Risk Factors” contained in Item 3
of our most recent Annual Report on Form 20-F. For further information,
please refer to the discussions in reports that QIAGEN has filed with,
or furnished to, the U.S. Securities and Exchange Commission (SEC).
LabCorp Forward-Looking Statements
This press release contains forward-looking statements including but
not limited to statements with respect to diagnostic solutions, the
impact of various factors on operating and financial results, and the
opportunities for future growth. Each of the forward-looking statements
is subject to change based on various important factors, including
without limitation, competitive actions and other unforeseen changes and
general uncertainties in the marketplace, changes in government
regulations, including healthcare reform, customer purchasing decisions,
including changes in payer regulations or policies, other adverse
actions of governmental and third-party payers, changes in testing
guidelines or recommendations, adverse results in material litigation
matters, the impact of changes in tax laws and regulations, failure to
maintain or develop customer relationships, our ability to develop or
acquire new products and adapt to technological changes, failure in
information technology, systems or data security, employee relations,
and the effect of exchange rate fluctuations. Actual results could
differ materially from those suggested by these forward-looking
statements. The Company has no obligation to provide any updates to
these forward-looking statements even if its expectations change.
Further information on potential factors, risks and uncertainties that
could affect operating and financial results is included in the
Company’s Form 10-K for the year ended Dec. 31, 2018, and subsequent
Forms 10-Q, including in each case under the heading risk factors, and
in the Company’s other filings with the SEC. The information in this
press release should be read in conjunction with a review of the
Company’s filings with the SEC including the information in the
Company’s Form 10-K for the year ended Dec. 31, 2018, and subsequent
Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
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Contacts
QIAGEN
Investor Relations
John Gilardi
e-mail:
ir@QIAGEN.com
+49 2103 29 11711
Public
Relations
Thomas Theuringer
Robert Reitze
e-mail: pr@QIAGEN.com
+49
2103 29 11826
+49 2103 29 11676
LabCorp
Investor
Relations
Clarissa Willett
e-mail: Investor@LabCorp.com
+1
336-436-5076
Media
Donald Von Hagen
e-mail: Media@LabCorp.com
+1
336-436-8263