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Chinese Regulators Approve AmoyDx's ALK, ROS1 Gene Fusion Detection Kits

NEW YORK (GenomeWeb) – Chinese molecular diagnostics firm Amoy Diagnostics this week announced it has received regulatory approval from the China Food and Drug Administration for two in vitro diagnostics kits.

The firm also said that the kits obtained CE marking in Europe.

The AmoyDx ROS1 Kit detects 14 ROS1 gene fusions, while the AmoyDx ALK/ROS1 Kit detects 26 ALK gene fusions and 14 ROS1 gene fusions. The kits use real-time PCR technology to analyze tumor messenger RNA from human tumor tissue or body fluids, and can provide results within 2.5 hours on most commercially available real-time PCR instruments.

The company has been working with drug developer OxOnc Development since August 2013 to provide the ROS1 gene fusion detection kit as a companion diagnostic for a pivotal clinical trial for Pfizer's ALK- and ROS1-inhibitor Xalkori (crizotinib) being conducted in the Asia-Pacific region, including China, Taiwan, Japan, and South Korea.

Along with its previous CFDA-approved EGFR mutation detection kit for clinical use, Amoy is getting closer to "real panel testing of relevant molecular biomarkers for currently available target therapies," Amoy Executive Vice President Mike Zhu said in a statement.

Chinese regulators approved the EGFR kit in 2010, the same year that the CFDA approved Amoy's KRAS detection kit. In March 2013 the agency approved Amoy's EML4-ALK Fusion Gene Detection Kit.