LabCorp and QIAGEN Announce New therascreen PIK3CA Mutation Analysis Companion Diagnostic for Metastatic Breast Cancer

New Therapy Specifically for Patients with PIK3CA Mutation in HR+/HER2-
Advanced Breast Cancer

BURLINGTON, N.C.–(BUSINESS WIRE)–LabCorp® (NYSE: LH), a leading global life sciences company that is
deeply integrated in guiding patient care, today announced a new
companion diagnostic called therascreen® PIK3CA PCR
mutation analysis, which is now available through LabCorp and its
Integrated Oncology specialty laboratory.


The test, developed by QIAGEN (NYSE: QGEN, Frankfurt Stock Exchange:
QIA), a world leader in Sample to Insight solutions for molecular
testing, identifies whether a patient has the specific gene mutation
that is a prerequisite for treatment with Piqray® (aplelisib), a new
therapy from Novartis for the treatment of postmenopausal women and all
men with hormone receptor positive, human epidermal growth factor
receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic
breast cancer, as detected by an FDA-approved test following progression
on or after an endocrine-based regimen. Piqray, in combination with
fulvestrant, and therascreen PIK3CA PCR mutation analysis assay
received approval from the U.S. Food and Drug Administration (FDA) on
May 24, 2019. LabCorp is able to make the test available quickly after
FDA approval through its participation in QIAGEN’s Day-One Lab Readiness
program, under which LabCorp began test validation and development of
operating protocols while the test was under regulatory review and is
therefore able to make the test available to patients just two weeks
after approval.

“Piqray (aplelisib), from Novartis, is the first and only therapy for
HR+/HER2- advanced breast cancer with a PIK3CA mutation,” said Marcia
Eisenberg, PhD, chief scientific officer, LabCorp Diagnostics. “Through
our collaboration with QIAGEN and participation in their Day-One Lab
Readiness Program, LabCorp is able to quickly make new companion
diagnostics available to help identify patients who are eligible for the
most innovative treatments, individualized to their disease. Enabling
patients to gain access to new treatments faster, furthering LabCorp’s
mission to improve health and improve lives.”

The American Cancer Society estimates that in 2019, there will be
268,600 new cases of breast cancer and approximately 70% will be
HR+/HER2-. For patients with HR+/HER2-advanced breast cancer,
approximately 40% have the PIK3CA mutation, which is associated with
tumor growth, resistance to endocrine treatment and a poor overall
prognosis.

The availability of this new companion diagnostic demonstrates LabCorp’s
continued leadership in companion diagnostics and precision medicine,
with the industry’s leading portfolio of tests that identify
personalized characteristics for each patient, and help guide more
specific treatment choices. For more than 20 years, long before they
joined forces, LabCorp Diagnostics and Covance Drug Development have
been involved in the development, commercialization and launch of
companion and complementary diagnostics, and together they have
supported more FDA-approved companion diagnostics than any other
company. Since 2018, the Company has collaborated with more than 75
clients on over 150 projects targeted at the development of new
companion diagnostics.

LabCorp joined QIAGEN’s Day-One Lab Readiness program in early 2019. In
addition to the therascreen PIK3CA PCR mutation analysis assay
announced today, LabCorp also recently launched the therascreen
FGFR mutation assay by RGQ RT-PCR for bladder cancer through the Day-One
program. Multiple other assays, including novel companion diagnostics
for lung, colorectal, bladder and other cancers, and eventually
pan-tumor disease areas, are currently in LabCorp’s Day-One Lab
Readiness pipeline.

“The promise of precision medicine is delivering the right drug to the
right patient at the right time, and it can be an absolute game-changer
for cancer patients,” said Dr. Dot Adcock, chief medical officer,
LabCorp Diagnostics. “LabCorp’s close relationships with numerous
hospitals, health systems, cancer clinics and oncologists across the
U.S. enables us to provide genetic testing for an increasing number of
patients, helping them to more quickly access the targeted therapy that
is right for them. We’re seeing extraordinary breakthroughs in precision
medicine in oncology patients, and it’s exciting to be a part of these
advances in patient care.”

For more information about LabCorp’s leadership role in precision
medicine, visit https://www.labcorp.com/about-us/labcorp-thought-leadership/.

Piqray® is a registered trademark of Novartis AG.

therascreen® is a registered trademark of QIAGEN N.V.

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 revenue of more than $11 billion
in 2018. To learn more about LabCorp, visit www.LabCorp.com,
and to learn more about Covance Drug Development, visit www.Covance.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but
not limited to statements with respect to clinical laboratory testing,
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, many
of which are beyond the Company’s control, 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, the Company’s satisfaction of
regulatory and other requirements, patient safety issues, changes in
testing guidelines or recommendations, adverse results in material
litigation matters, 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, and employee relations. These factors, in some cases,
have affected and in the future (together with other factors) could
affect the Company’s ability to implement the Company’s business
strategy and actual results could differ materially from those suggested
by these forward-looking statements. As a result, readers are cautioned
not to place undue reliance on any of our forward-looking statements.
The Company has no obligation to provide any updates to these
forward-looking statements even if its expectations change. All
forward-looking statements are expressly qualified in their entirety by
this cautionary statement. Further information on potential factors,
risks and uncertainties that could affect operating and financial
results is included in the Company’s most recent Annual Report on Form
10-K and subsequent Forms 10-Q, including in each case under the heading
RISK FACTORS, and in the Company’s other filings with the SEC.

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) and Life Sciences (academia, pharma R&D and industrial
applications, primarily forensics). As of March 31, 2019, QIAGEN
employed approximately 5,100 people in over 35 locations worldwide.
Further information can be found at www.qiagen.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,
collaborations markets, strategy or operating results, including without
limitation its expected adjusted net sales and adjusted diluted earnings
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. 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).

Contacts

LabCorp
Media:
Donald
Von Hagen, 336-436-8263
[email protected]

Investors:
Clarissa
Willett, 336-436-5076
[email protected]

QIAGEN
Investor
Relations:

John Gilardi, +49 2103 29 11711
Phoebe Loh, +49
2103 29 11457
e-mail: [email protected]

Public
Relations:

Thomas Theuringer, +49 2103 29 11826
Robert
Reitze, +49 2103 29 11676
e-mail: [email protected]

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