AmoyDx ROS1 Kit Approval in Taiwan, China
Date:2018-12-18Source: AmoyDx

Recently AmoyDx ROS1 gene fusion detection kit (fluorescence PCR method) was approved by Taiwan, China Food and Drug AdministrationTFDA). This approval signs a scientific basis for the clinical treatment to be provided to patients with non-small cell lung cancer (NSCLC) in Taiwan, China. Prior to this, the AmoyDx ROS1 Gene Fusion Detection Kit has been approved by China NMPA, Japan PMDA and Korea MFDS and CE certified in the European Union. The product is simple, convenient, accurate, and applicable to a wide range of sample types. It is an irreplaceable companion diagnostic reagent for clinical treatment of lung cancer patients, providing the highest scientific standard for clinical diagnosis.
Crizotinib is a NSCLC-targeted drug for the treatment of ROS1 fusion-positive, and its large-scale phase II clinical study (OO-1201) for Asia-Pacific NSCLC patients is very gratifying: objectively effective 69%, median progression-free survival 13.4 months. The research was carried out in East Asia by some renowned lung cancer experts including Professor Koichi Goto and Professor Yilong Wu. Based on the positive data from this clinical study, AmoyDx ROS1 kit has been approved as companion diagnostics kit for Crizotinib in Japan and Korea and enlisted into Japanese health insurance. With the approval by TFDA in Taiwan, China, AmoyDx ROS1 kit will benefit more lung cancer patients from precision medicine therapy.
There are more than 1.5 million new NSCLC patients in the world each year, about 2% have a tumor cause of ROS1 gene fusion. ROS1 gene fusion is another clear target for NSCLC target drug therapy following EGFR gene mutation and ALK gene fusion.

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