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AmoyDx Lung Cancer CDx Approved in South Korea

NEW YORK (GenomeWeb) — Chinese diagnostics firm AmoyDx announced this month that South Korea's Ministry of Food and Drug Safety has approved its ROS1 fusion assay as a companion diagnostic for Pfizer's non-small cell lung cancer (NSCLC) drug Xalkori (crizotinib).

Xalkori inhibits the oncogenes ROS1 and ALK. AmoyDx's PCR-based assay identifies 14 ROS1 gene fusions by analyzing tumor messenger RNA from human tumor tissue or body fluids, providing results in around 2.5 hours. AmoyDx noted that ROS1 gene rearrangements occur in about 2.4 percent of Asian NSCLC patients.

The assay received CE marking in 2013. It was approved by China's Food and Drug Administration in 2014 and in Japan in 2017.