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

San Francisco, CA, USA (UroToday.com) --  QIAGEN 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.

Novel therascreen® FGFR RGQ RT-PCR Kit will aid in identifying patients eligible for treatment with BALVERSA™ (erdafitinib), developed 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 therapy with a QIAGEN companion diagnostic assay. For more information on QIAGEN’s companion diagnostics please visit www.qiagen.com.


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