QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer

Novel therascreen® FGFR RGQ RT-PCR Kit will
aid in identifying patients eligible for treatment with BALVERSA

(erdafitinib), developed by Janssen

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24QGEN&src=ctag” target=”_blank”gt;$QGENlt;/agt;–QIAGEN N.V. (NYSE:QGEN; Frankfurt Prime Standard:QIA) today announced
the U.S. launch of its novel therascreen® FGFR
RGQ RT-PCR Kit (therascreen FGFR Kit) as a companion diagnostic
to help guide the use of the newly approved FGFR kinase inhibitor,
BALVERSA (erdafitinib), developed by Janssen Biotech, Inc.
(Janssen). The test will aid in identifying patients with urothelial
cancer whose tumors have certain alterations in the fibroblast growth
factor receptor 3 (FGFR3) gene. The U.S. Food and Drug Administration
co-approved the new test with BALVERSA™, as announced today by Janssen.

Urothelial cancer begins in tissues lining the bladder and other
genitourinary organs and is the sixth most common type of cancer in the
United States. An estimated 15,000 patients a year in the United States
are diagnosed with advanced or metastatic urothelial cancer, but current
treatment options are limited so the prognosis is poor. A percentage of
urothelial carcinoma tumors have certain FGFR alterations which are
thought to be key drivers of tumor growth. Detection of these
alterations utilizing the companion diagnostic will help identify
patients eligible for treatment with BALVERSA. The therascreen
FGFR Kit will run on QIAGEN’s Rotor-Gene Q MDx, a member of the modular
QIAsymphony family of automation solutions and leverages a worldwide
exclusive license for in-vitro diagnostic use of FGFR3:TACC3 fusions
from Columbia University.

“We are very excited about the launch of the new therascreen FGFR
Kit, the first companion diagnostic test to obtain FDA approval for
detection of FGFR gene alterations to guide therapy in any cancer
indication. Using our test to help guide treatment decisions in
urothelial cancer will address a high unmet medical need among
patients,” said Thierry Bernard, Senior Vice President and Head of
QIAGEN’s Molecular Diagnostics Business Area. “The new therascreen
FGFR Kit and significant testing capacities at leading laboratories will
be available through QIAGEN’s Day-One Lab Readiness program to
accelerate the availability of innovations in Precision Medicine.”

An updated list of laboratories offering the new therascreen FGFR
Kit under QIAGEN’s Day-One Lab Readiness program is available on
QIAGEN’s FGFR lab finder web page (www.qiagen.com/fgfr-lab-finder).

QIAGEN is a pioneer in Precision Medicine and the global leader in
collaborations with pharmaceutical and biotechnology companies to
co-develop companion diagnostics, which detect clinically relevant
genetic abnormalities to provide insights that guide clinical
decision-making on the use of drugs in diseases such as cancer. QIAGEN
has an unmatched depth and breadth of technologies from NGS to PCR for
companion diagnostic development and is currently working under master
collaboration agreements with more than 25 companies to develop and
commercialize companion diagnostic tests for their drug candidates. The therascreen
FGFR Kit co-approval with BALVERSA marks the sixth FDA approval of a
therapy with a QIAGEN companion diagnostic assay. For more information
on QIAGEN’s companion diagnostics please visit www.qiagen.com.


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 approximately 5,000 people in over 35
locations worldwide.

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).

BALVERSA is a trademark of Janssen Biotech, Inc.


Investor Relations
John Gilardi
+49 2103 29 11711

Phoebe Loh
+49 2103 29 11457

Public Relations
Dr. Thomas Theuringer
+49 2103 29 11826

Robert Reitze
+49 2103 29 11676

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