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

By April 15, 2019News
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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.

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