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Japan Regulators Approve AmoyDx's Lung Cancer CDx

NEW YORK (GenomeWeb) – Chinese firm Amoy Diagnostics said today that Japan regulators have approved its ROS1 fusion PCR assay as a companion diagnostic for Pfizer's ROS1 inhibitor Xalkori (crizotinib).

Japan's Pharmaceuticals and Medical Devices Agency approved the OncoGuide AmoyDx ROS1 fusion kit for identifying advanced non-small cell lung cancer patients with ROS1 gene fusions. Based on RT-PCR technology, the kit identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids. Results can be achieved in 2.5 hours.

The kit received CE mark in 2013 and was approved by China's Food and Drug Administration in 2014. AmoyDx CEO Li-Mou Zheng said in a statement that the firm expects to soon receive regulatory approval for the kit in South Korea and Taiwan.