Amoy Diagnostics of Xiamen, China today announced that it has received regulatory approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its ROS1 fusion PCR assay as a companion diagnostics for Pfizer’s ROS1 inhibitor Xalkori (Crizotinib).
October 1, 2018–Amoy Diagnostics of Xiamen, China today announced that it has received regulatory approval from South Korea's Ministry of Food and Drug Safety (MFDS) for its ROS1 fusion PCR assay as a companion diagnostics for Pfizer's ROS1 inhibitor Xalkori (Crizotinib).
AmoyDx ROS1gene fusions detection kit is approved as「AmoyDx ROS1 Gene Fusions Detection Kit」by Clinomics Inc. (AmoyDx’s Distributor in South Korea), to identify advanced non-small cell lung cancer (NSCLC) patients who habor ROS1 gene fusion and therefore might benefit from crizotinib. ROS1 gene rearrangements occur in about 2.4% of Asian patients with NSCLC. An estimated 1.5 million new cases of NSCLC are diagnosed worldwide each year.
AmoyDx ROS1 fusion kit detects 14 ROS1 gene fusions, which uses RT-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 kit has also obtained CE mark in 2013 and Chinese NMPA approval in 2014.
The MFDS’s approval of companion diagnostics is based on the data from the clinical study used to support the approval. Phase II Study of Crizotinib in East Asian had shown durable responses in 127 patients with ALK-negative and ROS1-positive metastatic NSCLC. The patients’ ROS1 status were determined using AmoyDx RT-PCR assay. The response rate on independent review was 71.7% (95% CI, 63.0% to 79.3%), with a median progression-free survival of 15.9 months*.
*Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non–Small-Cell Lung Cancer
About AmoyDx
Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights of ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits including but not limited to EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kit, which were firstly approved by CFDA and CE certified.
