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AmoyDx® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for TABRECTA™ (Capmatinib)

TOKYO and XIAMEN, May 20th, 2024 -- 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 TABRECTA™ (capmatinib) a product of Novartis AG, Basel, Switzerland which was approved by the Japanese MHLW in June 2020. Designed for patients battling unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations, TABRECTA™ tablets are available in 150 mg and 200 mg dosages.

Engineered using cutting-edge PCR technology, the AmoyDx® 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 twelve 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 capmatinib, thereby expanding their therapeutic options. We look forward to developing and commercializing additional, new therapy options for Japanese patients,” said 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.


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