Amoy Diagnostics Co. LTD. Got CFDA Approval For Its ROS1 And ALK&ROS1 Testing Kits

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Sept 1, 2014, Xiamen, China -- Amoy Diagnostics Co, Ltd. (AmoyDx), a provider of oncology molecular diagnostics products and services, announced today that it has received Chinese FDA (CFDA) approval for its proprietary IVD gene fusions detection kits: AmoyDx® ROS1 Kit detecting 14 ROS1 gene fusions, and AmoyDx® ALK&ROS1 Kit detecting 26 ALK gene fusions and 14 ROS1 gene fusions. These highly sensitive assays use real-time PCR technology to analyze tumor messenger RNA from human tumor tissue or body fluids and can derive results within 2.5 hours on majority of commercial available Real-Time PCR machines. These two kits also got CE-mark in Europe.

The importance of ALK and ROS1 gene fusions are indicated in National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Non-small Cell Lung Cancer (NSCLC), where ALK and ROS1 gene fusions described as predictive biomarkers of tumor response to ALK/ROS1 inhibitors such as Crizotinib (Xalkori®). Patients with ALK-positive or ROS1-positive NSCLC more likely benefit from ALK/ROS1 inhibitor treatment. Since August, 2013, AmoyDx started cooperation with OxOnc Development LP by providing ROS1 gene fusion detection kit as companion diagnostics for a pivotal clinical trial of Pfizer's Crizotinib conducted in Asia Pacific region including China (Mainland and Taiwan), Japan and South Korea.

‘With this new CFDA approved AmoyDx ALK/ROS1 fusion detection kit and previous CFDA approved EGFR mutation detection kit for clinical use, we are getting closer to a real panel testing of relevant molecular biomarkers for currently available target therapies. We are expecting that there are more and more patients with NSCLC benefiting from this companion diagnostics and target therapies’, said Dr. Mike Zhu, Executive Vice President of Amoy Diagnostics Co., LTD.

About Amoy Diagnostics Co., Ltd

AmoyDx is an R&D based provider of state-of-the-art diagnostic products and services in the area of human oncology personalized healthcare. Its customers include healthcare providers, academic institutions, and pharmaceutical companies. The company has a rich portfolio of oncology molecular testing products including kits for detection of EGFR mutations, EML4-ALK fusions, KRAS mutations, BRAF mutations, PIK3CA mutations, ROS1 fusions, and ALK&ROS1 fusions that have received CFDA approval and CE-mark, and this portfolio is keeping growing. Amoy Diagnostics is one of market leaders in the field of oncology companion diagnostics for personalized healthcare globally and its products have been widely used in more than 40 countries and most major hospitals in China.


Paul Huang
Director, Global Business
Amoy Diagnostics Co., Ltd.
Xiamen, China
Tel: +86-592-680.6058
Fax: +86-592-680.6839

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