AmoyDx® Pan Lung Cancer PCR Panel approved in Japan as the primary companion diagnostic for IBTROZI® (taletrectinib adipate)

On September 19, 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 Taletrectinib adipate (IBTROZI®).  

This approval applies to patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with ROS1 gene fusion. Furthermore, the AmoyDx® PLC Panel is the only multiplex genetic test approved in Japan as a companion diagnostic for Taletrectinib adipate (as of September 2025).

In 2023, Nippon Kayaku entered into an exclusive license agreement with AnHeart Therapeutics Inc., a Nuvation Bio Inc. company, to market and distribute IBTROZI® in Japan and obtained manufacturing and marketing approval.

Developed using cutting-edge PCR technology, the AmoyDx® PLC Panel enables the simultaneous detection of activating alterations in 11 key driver genes: EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3. It also identifies actionable mutations in seven of these genes (EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, KRAS, and RET) that are directly associated with 19 targeted therapies for NSCLC. This approval marks a significant advancement in precision oncology, offering rapid and sensitive mutation detection that can substantially improve patient outcomes.

"With this approval, the AmoyDx® PLC Panel is now available as a companion diagnostic to identify patients in Japan with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring ROS1 fusions who may benefit from treatment with IBTROZI®. This marks an important step forward in expanding therapeutic options for these patients," said Yuko Oi, President and CEO of Riken Genesis; Li-Mou Zheng, Ph.D., Founder and Chairman of AmoyDx; and Tatsuya Ikeda, President and CEO of PREMIA.

About AmoyDx PLC Panel: