Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Medicine Asia Co., Ltd. (“PREMIA”) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved AmoyDx® Pan Lung Cancer PCR Panel (the “AmoyDx PLC Panel”) as a companion diagnostic for Haiyitan® (gumarontinib), product of Haihe Biopharma KK Haiyitan® in 50 mg tablet form, approved by the MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with exon 14 (METex14) skipping mutations.
Manufactured using state-of-the-art PCR technology, AmoyDx® The PLC panel enables simultaneous detection of activation changes in 11 critical driver genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3) and identifies active mutations in seven of these genes (EGFR) , ROS1, BRAF, METex14 skipping, KRAS, RET) directly associated with sixteen NSCLC targeted therapies. This approval marks a transformative step forward in precision cancer therapy, combining rapid, sensitive detection with the potential to significantly improve patient outcomes.
With this approval, AmoyDx® The PLC panel can be used to identify advanced NSCLC patients harboring METex14 missense alterations for treatment with goumarotinib hydrate, thus expanding their treatment options. We look forward to developing and commercializing additional, novel treatment options for Japanese patients.”
Kenji Iwakabe, President and CEO of Riken Genesis, Li-Mou Zheng, Ph.D., Founder and CEO of AmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA
For 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, MET exon 14 skipping mutation, KRAS gene mutations and SOAK fusion genes in nucleic acids extracted from tumor tissue. It is used as an adjunct to determine the indications of the following fifteen antineoplastic agents for patients with NSCLC. ·EGFR gene mutation Gefitinib, Erlotinib hydrochloride, Afatinib maleate and Osimertinib mesylate ·ALK fusion gene Crizotinib, Alectinib hydrochloride and Brigatinib ·ROS1 fusion gene Crizotinib and entrectinib ·BRAF V600E mutation Combined administration of Dabrafenib mesylate and Trametinib dimethyl sulfoxide ·MET exon 14 skipping mutation Tepotinib, Capmatinib and Gumarontinib · KRAS G12C mutation Sotorasib ·SOAK fusion gene Selpercatinib |
| (4) Test method | Real-time PCR |
| (5) Sample | 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. |
