FDA Approves Qiagen’s Therascreen Urothelial Cancer Companion Diagnostic
Executive Summary
The Therascreen FGFR kit helps identify urothelial tumors with alterations to the fibroblast growth factor receptor 3 gene that indicate the cancer will respond to Janssen’s new drug Balversa.
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.
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