QIAGEN launches first FDA-approved companion diagnostic tool for FGFR alteration and targeted treatment of metastatic urothelial carcinoma

Monday, April 15, 2019

QIAGEN NV today announced the US launch of its new therascreen ® FGFR RGQ RT-PCR Kit ( therascreen FGFR Kit) as an adjunctive diagnostic investigator, using the recently approved FVRI kinase inhibitor BALVERSA ™ developed by Janssen Biotech, Inc. (Janssen)(erdafitinib) supported. The test will help identify patients with urothelial carcinoma whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene (FGFR3 gene). The US Food and Drug Administration (FDA) has approved the new test along with BALVERSA ™, as Janssen announced today.

Urothelial carcinomas appear first in the bladder lining tissues and other urogenital organs and are the sixth most common cancer in the United States. An estimated 15,000 cases of advanced or metastatic urothelial cancer are diagnosed annually in the United States. The prognosis is poor due to limited current treatment options. A certain percentage of urothelial carcinomas have certain FGFR alterations that are considered to be crucial factors in tumor growth. Identifying these alterations using the companion diagnostic identifies patients suitable for treatment with BALVERSA. The therascreenRunning on QIAGEN's Rotor-Gene Q MDx platform, which is part of the modular QIAsymphony suite of automation solutions, the FGFR kit utilizes a worldwide exclusive license for use as an in vitro diagnostic of FGFR3: TACC3 fusions Columbia University.

"We are excited to announce the launch of the new therascreen FGFR kit, the first FDA-approved companion diagnostic test for the identification of alterations in the FGFR gene, which allows targeted treatment of cancer indications. Leveraging our test to guide treatment decisions in urothelial carcinoma meets high healthcare needs, "said Thierry Bernard, senior vice president and head of QIAGEN's Molecular Diagnostics Business Unit. "The new therascreen Leading-edge FGFR kits and extensive testing capabilities will be available through QIAGEN's "Day-One Lab Readiness" program to accelerate the availability of new methods in precision medicine. "

For an updated list of laboratories offering the new therascreen FGFR Kit as part of QIAGEN's Day-One Lab Readiness Program, visit QIAGEN's FGFR Laboratory Search Website ( www.qiagen.com/fgfr -lab-finder ).

QIAGEN is a pioneer in the field of precision medicine and a world leader in collaborating with pharmaceutical and biotechnology companies to jointly develop companion diagnostics that detect clinically relevant genetic anomalies. In this way, insights are gained that support clinical decisions about the use of drugs in diseases such as cancer. QIAGEN offers an unparalleled variety of technologies - from next-generation sequencing to polymerase chain reaction - for the development of companion diagnostics, and is currently working to develop and commercialize companion diagnostic tests for its drug candidates through collaborative agreements with more than 25 companies. The approval of thetherascreen FGFR kits along with BALVERSA is the sixth approval by the FDA of a therapy that uses QIAGEN's companion diagnostic test. For more information about QIAGEN  Companion Diagnostics, visit www.qiagen.com .

About QIAGEN

QIAGEN NV is a Dutch holding company and the world's leading provider of sample preparation and testing technologies, enabling customers to gain valuable insights at a molecular level. Sample preparation technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Test technologies are used to visualize such isolated biomolecules and to prepare them for analysis. Bioinformatics solutions and knowledge bases help interpret data to gain relevant and practical insights. Automation solutions combine these into seamless and cost-effective test workflows. QIAGEN provides these workflows to more than 500,000 customers worldwide from the areas of molecular diagnostics (health care), applied testing (mainly forensics), pharmaceuticals (pharmaceutical and biotechnology companies) and research (life sciences). As of December 31, 2018, QIAGEN had approximately 5,000 employees worldwide at more than 35 locations.

Forward-looking statement

which are associated with manifold uncertainties and risks. These include, but are not limited to: risks associated with growth management and international business activities (including the effects of currency fluctuations and dependence on regulatory and logistics processes); Fluctuations in operating results and their distribution among our customer groups; the development of the markets for our products to customers in Academic Research, Pharmaceuticals, Applied Testing and Molecular Diagnostics; Changing our relationships with customers, suppliers and strategic partners, the competitive environment, rapid or unexpected technological change, Fluctuations in the demand for QIAGEN products (including general economic developments, the size and availability of our clients' budgets and other factors), the opportunity to obtain regulatory approval for our products, difficulties in adapting QIAGEN's products to integrated solutions and the Manufacture of such products, the ability of the company to develop and implement new product ideas, differentiate itself from competitors' products and protect against competition, market acceptance of new products and the integration of acquired businesses and technologies; and other factors discussed under "Risk Factors" in paragraph 3 of the current Annual Report Form 20-F.

BALVERSA is a trademark of Janssen Biotech, Inc.

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