LabCorp Announces Availability of New QIAGEN therascreen FGFR mutation analysis companion diagnostic for Bladder Cancer

New Test Further Underscores LabCorp’s Leadership in Development and
Commercialization of Innovative Lab Testing

BURLINGTON, N.C.–(BUSINESS WIRE)–LabCorp® (NYSE: LH), a leading global life sciences company that is
deeply integrated in guiding patient care, today announced the
availability of a newly-approved companion diagnostic by the U.S. Food
and Drug Administration (FDA), the therascreen® FGFR mutation assay
, which is now available for ordering from LabCorp and
its Integrated Oncology specialty laboratory.

QIAGEN developed the assay, which is used to assess the eligibility of
patients with urothelial cancer for treatment with the newly approved
FGFR kinase inhibitor, BALVERSA (erdafitinib), developed by
Janssen Biotech, Inc. (Janssen). This is the first FDA-approved
biomarker-driven, targeted therapy for the treatment of adults with
locally advanced or metastatic urothelial carcinoma (mUC) with
susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic
alterations and who have progressed during or following at least one
line of prior platinum-containing chemotherapy, including within 12
months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Since 2018, the Company collaborated with more than 75 clients on over
150 projects targeted at the development of new companion diagnostic
tests. The availability of this new assay reflects LabCorp’s continued
leadership in precision medicine. For more than 20 years, 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.

The therascreen FGFR mutation analysis assay is the first to be
introduced through LabCorp’s participation in QIAGEN’s Day-One Lab
Readiness program, under which LabCorp will make novel companion
diagnostics available for use by physicians soon after the FDA has
approved a new treatment and its associated test.

“LabCorp is committed to bringing precision testing to patients as
quickly as possible,” said Marcia Eisenberg, PhD, chief scientific
officer, LabCorp Diagnostics. “Our work on studies supporting regulatory
approval of the therascreen® FGFR mutation analysis companion
diagnostic for BALVERSA, and our commitment to make the test available
to physicians and patients as soon as possible after approval, aligns
with our mission to improve health and improve lives. LabCorp offers
end-to-end support for diagnostic development and accelerated
commercialization, distinctly positioning us at the intersection of
research and patient care.”

Urothelial cancer, or transitional cell carcinoma (TCC), is the most
prevalent form of bladder cancer, which constitutes the sixth most
common type of cancer in the U.S. According to the American Cancer
Society, more than 80,470 new cases of bladder cancer will be diagnosed
in 2019, and will result in approximately 17,600 deaths. For patients
with metastatic disease, outcomes are dire, with a relative five-year
survival rate of only five percent.

For more information about LabCorp’s full menu of companion and
complementary diagnostic tests, visit

BALVERSA® is a trademark of Janssen Biotech, Inc.

therascreen® is a trademark of QIAGEN

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,
and to learn more about Covance Drug Development, visit

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but
not limited to statements with respect to drug development, medical
device and diagnostic development solutions, 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.


Media: Donald Von Hagen — 336-436-8263
Clarissa Willett — 336-436-5076

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