Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. and Precision Medicine Asia Co., Ltd. Announce Ministry of Health, Labour and Welfare Approves Companion Diagnostic for Tepmetko®
August 16, 2021 at 10:00 pm EDT
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Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. and Precision Medicine Asia Co., Ltd. announced that the 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 TEPMETKO® (tepotinib) a Merck KGaA, Darmstadt, Germany product that received approval by the Japanese MHLW in March 2020. TEPMETKO (tepotinib) is approved for use in patients with unresectable, advanced or recurrent non-small cell lung cancer with MET gene exon 14 skipping alterations. The AmoyDx®PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of 11 driver genes (EGFR/ALK/ROS1/KRAS/BRAF/HER2/RET/MET/NTRK1/NTRK2/NTRK3 genes) when all genes on the panel are approved as companion diagnostics. The AmoyDx®PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping) for ten associated targeted therapies in NSCLC. With its high sensitivity and short turnaround time, The AmoyDx®PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.
Amoy Diagnostics Co Ltd is a pharmaceutical company engaged in research, development, production and sales of molecular diagnostic products. The Company provides testing reagents and testing services for tumor diagnosis. The Companyâs testing reagent products include ADx-ARMS product line for tumor tissue specimen detection, Super-ARMS product line for liquid biopsy, the NGS product line and the FISH product line. The products are used for the detection of non-small cell lung cancer, colorectal cancer, thyroid cancer, melanoma and other malignant tumors. The Company also provides data software to capture and analyze gene sequencing data. The Company provides testing services through its own medical testing institutions, including lung cancer testing, colorectal cancer testing and breast cancer testing.
Riken Genesis Co., Ltd., Amoy Diagnostics Co., Ltd. and Precision Medicine Asia Co., Ltd. Announce Ministry of Health, Labour and Welfare Approves Companion Diagnostic for Tepmetko®