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Amoy Diagnostics PLC Panel Gets Approval in Japan as CDx for Retevmo in Non-Small Cell Lung Cancer

NEW YORK – Riken Genesis, Amoy Diagnostics, and Precision Medicine Asia said Monday that the Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved the AmoyDx Pan Lung Cancer PCR Panel as a companion diagnostic to direct the use of Eli Lilly's Retevmo (selpercatinib) in RET fusion-positive non-small cell lung cancer.

The AmoyDx PLC panel uses PCR to simultaneously evaluate the presence of activation alterations in 11 driver genes — EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NTRK1, NTRK2, and NTRK3 — and has received CDx approval for 12 associated targeted therapies in NSCLC.

AmoyDx claims high sensitivity and a short turnaround time for the assay, which it said should help establish its test as an "important clinical diagnostic in guiding treatment opportunities for NSCLC patients."

Executives from AmoyDx, Riken Genesis (the marketing authorization holder for the test in Japan), and Precision Medicine Asia said in a statement that the three companies also look forward to developing and commercializing additional, new therapy options for Japanese patients.

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