Amoy Diagnostics Achieved CFDA Approval For Its EGFR&ALK&ROS1 Testing Kit
Date:2016-02-05Source: AmoyDx
Amoy Diagnostics Co., Ltd. (AmoyDx), a provider of oncology molecular diagnostics products and services, announced today that it has got Chinese FDA (CFDA) approval for its multiple gene mutations detection kit: EGFR/ALK/ROS1 panel detecting 18 EGFR mutations, 5 ALK fusions and 9 ROS1 fusions simultaneously. The highly sensitive assay uses one step real-time PCR (combined reverse transcription and PCR amplification technology) to analyze EGFR, ALK, and ROS1 gene status in human NSCLC (non-small cell lung cancer) tissue samples. The kit also got CE-mark in Europe.
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