AmoyDx® Lung Cancer Multi-gene PCR Panel Approved as Cross-sectional Companion Diagnostic for EGFR Gene Mutations in Non-Small Cell Lung Cancer
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Riken Genesis Co., Ltd. announced that on April 28, 2026, it obtained a partial change approval for the manufacturing and marketing of its in vitro diagnostic medical device, the "AmoyDx® Lung Cancer Multi-gene PCR Panel." This approval allows the product to be used as a cross-sectional companion diagnostic (CDx) for EGFR gene mutations in non-small cell lung cancer, aiding in the determination of applicability for multiple approved anti-cancer drugs (EGFR molecular targeted therapies), thereby contributing to expanding treatment opportunities for patients.