• February 3, 2017–Amoy Diagnostics of Xiamen, China today announced that it has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its ROS1 fusion PCR assay as a companion diagnostics for Pfizer's ROS1 inhibitor Xalkori (crizotinib).
AmoyDx ROS1 fusion kit is approved as「OncoGuide AmoyDx ROS1融合遺伝子検出キット」by Riken Genesis (AmoyDx’s MAH in Japan), 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 FDA approval in 2014.
The PMDA’s approval of companion diagnostics is based on the data from the clinical study used to support the approval. In June 2016, American Society of Clinical Oncology (ASCO) Annual Meeting posted that the Phase II clinical trial of crizotinib in East Asia 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 69% (95% CI: 61–77), with a median progression-free survival of 13.4 months.
“We are excited for the approval of ROS1 kit in Japan, which is the first Chinese product for Companion Diagnostics on precision medicine,” said Dr. Li-Mou Zheng, CEO of AmoyDx, “and next step, we will soon receive regulatory approval in South Korea and Taiwan,China to expand the use of ROS1 testing.”
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.
In European EMQN and Chinese PQCC programs, AmoyDx is the NO.1 testing kits supplier for some years and always achieves the highest accuracy rate. Nowadays AmoyDx serves an extensive domestic and international oncology network reaching over 300 hospitals in China and 50 countries all over the world. Every year hundreds of thousands of cancer patients are benefitted from AmoyDx products. AmoyDx is strategic partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical studies in gene tissue and blood testing.
About Riken Genesis
Riken Genesis Co., Ltd. was established in 2007 as a Riken venture company and contract genomics analysis service provider, leveraging the genome analysis resources of Riken Research Institute.