Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. and Precision Medicine Asia Co., Ltd. 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 for RET fusion-positive non-small cell lung cancer ("NSCLC"), for selpercatinib capsules 40 mg and 80 mg. The AmoyDx®?PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ALK/ROS1/KRAS/BRAF/HER2/RET/NTRK1/NTRK2/NTRK3 genes) when all genes on the panel are approved as companion diagnostics.

The AmoyDx PLC Panel has received approval for the identification of activating alterations in seven driver genes (EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, KRAS, and RET) for twelve (12) associated targeted therapies in NSCLC. With its high sensitivity and short turnaround time, the AmoyDx®PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients. Approval No.

30300EZX00069000. Product name: AmoyDxPan Lung Cancer PCR Panel. Testing method: Real-time PCR.

Sample: FFPE tissue and fresh frozen tissue in which the presence of tumor cells was confirmed. Package size: 12 tests /kit. Marketing Authorization Holder: Riken Genesis Co., Ltd. Manufacturer: Amoy Diagnostics Co., Ltd.