South Korea Health Regulator Clears Non-Small Cell Lung Cancer Diagnostic

South Korea’s Ministry of Food and Drug Safety granted approval for AmoyDx’s ROS1 fusion assay as an accompanying diagnostic for Pfizer’s non-small cell lung cancer medicine Xalkori (crizotinib).

The PCR-based assay received the CE Mark in 2013 and was approved in China and Japan in 2014 and 2017, respectively.

The assay analyzes tumor messenger RNA from tissue or body fluids to identify 14 ROS1 gene fusions that can lead to cancer.