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

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QIAGEN N.V. 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 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.”