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AmoyDx PCR Panel Receives Japanese Approval as CDx for Non-Small Cell Lung Cancer Therapies

NEW YORK ─ Riken Genesis, Amoy Diagnostics, and Precision Medicine Asia on Wednesday announced that the Japanese Ministry of Health, Labour, and Welfare has approved the AmoyDx Pan Lung Cancer PCR Panel for production and marketing in Japan.

The real-time PCR panel, manufactured by Xiamen, China-based AmoyDx, is an IVD reagent developed as a CDx for multiple anti-cancer agents.

The test, also called the AmoyDx PLC Panel, has received approval for four driver genes — EGFR, ALK, ROS1, and BRAF — for nine associated targeted therapies in non-small cell lung cancer. It is expected to be an important clinical diagnostic in guiding treatment for advanced NSCLC patients, the firms said.

"The approval of the AmoyDx PLC Panel marks the first time that Japanese patients will have direct access to a locally administered multi-gene PCR CDx with a very short turnaround time from sample to diagnosis," Li-Mou Zheng, founder and CEO of AmoyDx, said in a statement.

The panel 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 firms said.

Riken Genesis and Precision Medicine Asia are based in Tokyo.