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 for Haiyitan® (gumarontinib), a product of Haihe Biopharma K.K. Haiyitan® in 50 mg tablet form, was approved by MHLW in June 2024 for patients with unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations.
Engineered using cutting-edge PCR technology, the AmoyDx® PLC Panel enables the simultaneous detection of activation alterations across 11 critical driver genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3) and identifies actionable mutations in seven of these genes (EGFR, ALK, ROS1, BRAF, METex14 skipping, KRAS, RET) directly linked to sixteen targeted NSCLC therapies. This approval signifies a transformative step forward in precision cancer treatment, combining rapid, sensitive detection with the potential to significantly enhance patient outcomes.
With this approval, the AmoyDx® PLC Panel can be used to identify advanced NSCLC patients harboring alterations leading to METex14 skipping for treatment with gumarontinib hydrate, thereby expanding their therapeutic options. We look forward to developing and commercializing additional, new therapy options for Japanese patients.”
Kenji Iwakabe, President and Chief Executive Officer of Riken Genesis, Li-Mou Zheng, Ph.D., Founder and Chief Executive Officer of AmoyDx and Wenn Sun, Ph.D., Founder and President 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, MET exon 14 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 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
・RET fusion gene
Selpercatinib |
| (4) Testing 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. |