QIAGEN and LabCorp Launch Collaboration to Provide Day-One Access for Patients to Innovative Companion
Diagnostics at the Time of Drug Approvals
LabCorp joins QIAGEN’s “Day-One” program designed to help deliver precision medicine to patients
faster
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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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
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