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.

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