AmoyDx® Pan Lung Cancer PCR PanelApproved in Japan as a Companion Diagnosticfor LORBRENA® (Lorlatinib)

TOKYO and XIAMEN, August 21, 2025 — Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. (“AmoyDx”), and Precision Medicine Asia Co., Ltd. (“PREMIA”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) as a companion diagnostic (CDx) for LORBRENA® (Lorlatinib). This approval applies to patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) harboring an ALK fusion gene. LORBRENA®, developed by Pfizer, is available globally, including in Japan, in 25 mg and 100 mg tablet formulations.

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JointRelease_ALK_Loratinib_approval_RG-Amoy-PREMIA_fin2.pdf

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