TOKYO and XIAMEN, 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:
About Riken Genesis Co., Ltd.
RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories. For more information, please visit www. rikengenesis.jp
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com.
About Precision Medicine Asia (PREMIA)
PREMIA offer an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also manages a clinical-genomic lung cancer registry, the largest in the region, which includes more than 20,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan, Taiwan, Malaysia and Thailand. For more information, please visit www.premia-inc.com
For media contacts:
Tatsuro Saito
General Manager, Marketing department
Tel: +81-3-5759-6042
info2@rikengenesis.jp
Robson Ee
Senior Director, International Business
info@amoydx.com
Tatsuya Ikeda
President and CEO
Tel: +81-3-5403-5973
info@premia-inc.com
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:
| (1) Product name | AmoyDx® Pan Lung Cancer PCR Panel |
| (2) Approval No. | 30300EZX00069000 |
| (3) Purpose of use | Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene, BRAF gene mutations, METex14 skipping mutation, KRAS gene mutations and RET fusion genes in nucleic acids extracted from cancer tissue. Used as an adjunct to determine the indications of the following 19 antineoplastic agents for patients with NSCLC. ・EGFR gene mutation Gefitinib, Erlotinib hydrochloride, Afatinib maleate, Osimertinib mesylate and Amivantamab plus Lazertinib mesylate hydrate ・ALK fusion gene Crizotinib, Alectinib hydrochloride, Brigatinib and Lorlatinib ・ROS1 fusion gene Crizotinib, Entrectinib, Repotrectinib and Taletrectinib adipate ・BRAF V600E mutation Combined administration of Dabrafenib mesylate and Trametinib dimethyl sulfoxide ・MET exon 14 skipping mutation Tepotinib, Capmatinib and Gumarontinib hydrate ・KRAS G12C mutation Sotorasib ・RET fusion gene Selpercatinib |
| (4) Method | Real-time PCR |
| (5) Specimen | FFPE tissue and fresh frozen tissue in which the presence of tumor cells was confirmed |
| (6) Package size | 12 tests / kit |
| (7) Marketing Authorization Holder |
Riken Genesis Co., Ltd. |
| (8) Manufacturer | Amoy Diagnostics Co., Ltd. |
About Riken Genesis Co., Ltd.
RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories. For more information, please visit www. rikengenesis.jp
About Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685)
AmoyDx is at the forefront of championing molecular diagnostics for cancer, committed to enhancing patient outcomes worldwide through innovative diagnostic solutions and breaking barriers for global precision oncology adoption. The company is recognized for its excellence in precision medicine, driving advancements in cancer diagnosis through its extensive collaboration with pharmaceutical companies. For more information, please visit www.amoydiagnostics.com.
About Precision Medicine Asia (PREMIA)
PREMIA offer an integrated platform for the development of innovative oncology therapies and diagnostics in Asia, the fastest growing market for the pharmaceutical industry. PREMIA also manages a clinical-genomic lung cancer registry, the largest in the region, which includes more than 20,000 patients and allows an efficient patient identification process for clinical trial enrollment through participation by more than 200 hospitals in Japan, Taiwan, Malaysia and Thailand. For more information, please visit www.premia-inc.com
For media contacts:
Tatsuro Saito
General Manager, Marketing department
Tel: +81-3-5759-6042
info2@rikengenesis.jp
Robson Ee
Senior Director, International Business
info@amoydx.com
Tatsuya Ikeda
President and CEO
Tel: +81-3-5403-5973
info@premia-inc.com
AmoyDx® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for LORBRENA® (Lorlatinib)
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