QIAGEN Launches First FDA-Approved Companion Diagnostic for FGFR Alterations to Guide Erdafitinib Therapy in Urothelial Cancer

Recently, in addition to Janssen Pharmaceuticals’ Balversa (erdafitinib), under Johnson & Johnson, receiving accelerated approval as the first targeted therapy for metastatic bladder cancer, the U.S. Food and Drug Administration (FDA) also approved Qiagen's companionDiagnosisTest device for detecting urothelial carcinoma associated with fibroblast growth factor receptor (FGFR) gene alterations.

On April 12, Qiagen announced the launch of the new therascreen FGFR RGQ RT-PCR Kit (therascreen FGFR Kit) as a companionDiagnosisto help guide the use of Balversa (erdafitinib), a newly approved FGFR kinase inhibitor developed by Johnson & Johnson. This trial will help identify whether patients with urothelial carcinoma have alterations in the fibroblast growth factor receptor 3 (FGFR3) gene.

As the first targeted therapy approved for patients with metastatic bladder cancer, Balversa is estimated to generate billions of dollars in sales for Janssen Pharmaceuticals and its parent company, Johnson & Johnson. This kinase inhibitor is approved for the treatment of advanced or metastatic bladder cancer in patients who have previously received chemotherapy and harbor FGFR2 or FGFR3 genetic mutations. The companion diagnostic kit is equally groundbreaking as Johnson & Johnson’s targeted drug; the therascreen PCR kit is the first approved for guiding FGFR gene mutation–related therapies in oncology indications.Diagnosis. This test kit will be run on Qiagen’s Rotor-Gene Q MDx, which is part of its modular QIAsymphony series of automated instruments, and holds Columbia UniversityIn Vitro DiagnosticsExclusive License Used.

According to Thierry Bernard, Head of Molecular Diagnostics at Qiagen, the company will conduct diagnostics and testing for corresponding patients in laboratories through its “Day-One Lab Readiness Program.” The preparation plan includes early workflow readiness, staff training, and new molecular assays currently required for targeted cancer therapies.DiagnosisValidation. Earlier this month, Qiagen also established a partnership with the independent laboratory LabCorp.

WHO Classification of Tumours: Pathology and Genetics of Tumours of the Urinary System and Male Genital OrgansHeredityIn the histological classification of urinary system tumors in "Learning", the pathological types of bladder cancer include bladder urothelial carcinoma, bladder squamous cell carcinoma, and bladder adenocarcinoma.FDAstates that bladder cancer is the sixth most common disease in the United States, with approximately 15,000 new cases annuallyDiagnosispatients, but current treatment options are limited, resulting in a poor prognosis. Approximately 20% of patients with recurrent or refractory disease harbor FGFR genetic alterations. A small phase II single-arm study involving 87 patients with bladder cancer demonstrated an overall response rate of 32.2% for the drug, and willTumorThe median progression-free survival was 5.4 months. Data from the full study showed that the median overall survival in the 12 patients who did not receive chemotherapy reached 13.8 months.

Thierry Bernard, Senior Vice President and Head of Qiagen’s Molecular Diagnostics Business Area, stated, “We are very excited to launch the new FGFR assay, which is the first to receiveFDACompanion diagnostic test device approved for detecting FGFR gene alterations to guide treatment across any cancer indication. Using our test can help guide treatment decisions in urothelial carcinoma, thereby addressing unmet medical needs in patients. The new thecreencreen FGFR Kit andDiagnosis"The testing service will be made available to a broad patient population through QIAGEN’s Day-One Lab Ready program, accelerating the availability of precision medicine innovations.”BioValleyBioon.com）