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Amoy Diagnostics CDx Gets Japanese Approval to ID NSCLC Patients Eligible for Tepmetko

NEW YORK – Amoy Diagnostics, Riken Genesis, and Precision Medicine Asia (Premia) on Monday said that Japan's Ministry of Health, Labor, and Welfare has approved the AmoyDx PLC Panel as a companion diagnostic to identify non-small cell lung cancer patients eligible for Merck KGaA's tepotinib (Tepmetko).

Specifically, the MHLW has approved the AmoyDx PLC Panel — short for Pan Lung Cancer PCR Panel — for use in identifying patients with unresectable, advanced, or recurrent NSCLC whose tumors harbor MET exon 14 skipping alterations, making them eligible for treatment with tepotinib.

The MHLW approved tepotinib in March 2020, and the US Food and Drug Administration followed suit the next year. In August 2020, AmoyDx struck a companion diagnostic development deal with Merck KGaA to seek companion diagnostic approval for its PLC Panel alongside tepotinib in Japan. Riken Genesis and Premia have collaborated with AmoyDx on securing the approval.

The MHLW's companion diagnostic approval marks the fifth such approval for the AmoyDx PLC Panel, which is a PCR-based panel designed to evaluate 11 NSCLC driver genes. The test also has Japanese companion diagnostic approval for identifying NSCLC patients with EGFR, ALK, ROS1, and BRAF alterations, making them eligible for respective targeted therapies.