Amoy Diagnostics Co.,Ltd.
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 kits, which were firstly approved by CFDA and CE certified.
In European EMQN and Chinese PQCC quality control programs, AmoyDx is the NO.1 testing kit 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 benefit from AmoyDx products.
AmoyDx is strategic diagnostics partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical oncology practice. AmoyDx ROS1 kit was recently approved by Japanese authority PMDA as the sole companion diagnostic kit for Pfizer’s crizotinib, which became the 1st approved CDx kit in the world for lung cancer patients’ ROS1 testing.
Our mission is to provide customers with superior and innovative products and services to improve healthcare and patients’ lives. Our vision is to be one of the global leading and most reliable suppliers of high quality diagnostic products and services for personalized healthcare.
We endeavor to accomplish this mission and vision by:
1. Adhering to the strictest manufacturing standards to provide quality products at competitive prices.
2. Maintaining an unsurpassed level of customer service and satisfaction.
3. Pursuing scientific innovation as we provide customers with practical leading-edge technologies and value-added products.
4. Creating a world-class organization that contributes positively to the lives of our employees, our customers, the patients and the scientific community.
Business Type:Manufacturer
Country/Region:China
Ddu Verified
HOT Rank
For qualitative detection of 26ALKgene fusionsand 14 ROS1gene fusions
ALKgene fusionsand ROS1 gene fusions define unique molecularsubsetsof non–small-cell lung cancer (NSCLC).EML4,KIF5B,TFG,KLC1etc., are identified as fusion partnersof ALK;SLC34A2,CD74,SDC4,EZRetc.,are identified as fusion partnersof ROS1.These fusions lead to constitutive kinase activity and activation of downstream pathways, leading to carcinogenesis.It has been reported that the presence of theALKgene fusions and ROS1gene fusionsarecorrelated with the efficacy of TKI therapy.
Detection of ALK and ROS1 fusions in patients with advanced NSCLC indicates eligibility for treatment with ALK inhibitor crizotinib.
The AmoyDx®ALK Gene Fusions and ROS1 Gene Fusions Detection Kitis an in vitronucleicacidamplification test intended for qualitative detection of 26 ALK gene fusions and 14 ROS1 gene fusions.
Intended Use
CFDA approved for clinical use in China and CE marked for IVD use in Europe.
Technological Principles
The kit is based on three major processes:
(1) Specimen preparation to isolate total RNA from NSCLC FFPE samples;
(2) Reverse transcription of the target RNA to generate complementary DNA (cDNA);
(3) Simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.
26 ALK and 14 ROS1 fusions detected by the panel:
