Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd., (“AmoyDx”) and Precision Drugs Asia Co., Ltd. (“PREMIA”) right this moment introduced that the Japanese Ministry of Well being, Labour and Welfare (MHLW) has accepted the AmoyDx® Pan Lung Most cancers PCR Panel (the “AmoyDx PLC Panel”) as a companion diagnostic for Haiyitan® (gumarontinib), a product of Haihe Biopharma Ok.Ok. Haiyitan® in 50 mg pill kind, was accepted by MHLW in June 2024 for sufferers with unresectable superior or recurrent non-small cell lung most cancers (NSCLC) with MET exon 14 (METex14) skipping mutations.
Engineered utilizing cutting-edge PCR know-how, the AmoyDx® PLC Panel permits the simultaneous detection of activation alterations throughout 11 vital driver genes (EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, NTRK3) and identifies actionable mutations in seven of those genes (EGFR, ALK, ROS1, BRAF, METex14 skipping, KRAS, RET) instantly linked to sixteen focused NSCLC therapies. This approval signifies a transformative step ahead in precision most cancers remedy, combining speedy, delicate detection with the potential to considerably improve affected person outcomes.
With this approval, the AmoyDx® PLC Panel can be utilized to establish superior NSCLC sufferers harboring alterations resulting in METex14 skipping for remedy with gumarontinib hydrate, thereby increasing their therapeutic choices. We sit up for growing and commercializing further, new remedy choices for Japanese sufferers.”
Kenji Iwakabe, President and Chief Govt Officer of Riken Genesis, Li-Mou Zheng, Ph.D., Founder and Chief Govt Officer of AmoyDx and Wenn Solar, Ph.D., Founder and President of PREMIA
About AmoyDx PLC Panel:
(1) Product title
AmoyDx® Pan Lung Most cancers PCR Panel
(2) Approval No.
30300EZX00069000
(3) Function 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 most cancers tissue.Used as an adjunct to find out the indications of the next fifteen antineoplastic brokers for sufferers with NSCLC.・EGFR gene mutation Gefitinib, Erlotinib hydrochloride, Afatinib maleate andOsimertinib mesylate・ALK fusion gene Crizotinib, Alectinib hydrochloride and Brigatinib・ROS1 fusion gene Crizotinib and Entrectinib・BRAF V600E mutation Mixed 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 methodology
Actual-time PCR
(5) Pattern
FFPE tissue and recent frozen tissue during which the presence of tumor cells was confirmed
(6) Package deal dimension
12 assessments / package
(7) Advertising and marketing Authorization Holder
Riken Genesis Co., Ltd.
(8) Producer
Amoy Diagnostics Co., Ltd.
