Amoy Diagnostics Co., Ltd. – AmoyDx
AmoiDx – Amoi Diagnostics Co., Ltd. focuses on molecular diagnostics for precision medicine in oncology. As the independent owner of the intellectual property rights of ADk-ARMS and Super-ARMS technologies, AmoiDx Company has a leading portfolio of molecular diagnostic equipment, including without limitation EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 test kits, initially approved by the Chinese Agency for the registration of medical devices (CFDA) and they also have a CE certificate.
According to the quality control programs, European EMKN and Chinese PKCC, AmoiDk company has been the number 1 supplier of test kits for several years and always achieves maximum accuracy. Today, AmoiDx serves an extensive domestic and international oncology network that includes over 300 hospitals in China and 50 countries around the world. Each year, hundreds of thousands of cancer patients benefit from AmoiDk products.
AmoiDx is a strategic partner with diagnostic companies such as AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, in providing diagnostic products and services for medical development and clinical oncology practice.
The AmoyDx ROS1 kit recently received approval from the Japanese Medicines and Medical Devices Agency (PMDA) as an exclusive diagnostic kit alongside Pfizer’s crizotinib, becoming the world’s first approved CDx kit for ROS1 testing in lung cancer patients. Our mission is to provide patients with superior and innovative products and services with the aim of improving health care and the quality of life of patients. Our vision is to become the leading global and most trusted provider of high-quality diagnostic products and services for personalized healthcare.
We strive to live up to our vision and mission by:
1. we adhere to the strictest manufacturing standards with the aim of offering quality products at competitive prices;
2. we maintain an unsurpassed level in servicing customer needs and creating customer satisfaction;
3. we work on scientific innovations while supplying customers with practical pioneering technologies and value-added products;
4. we are creating a world-class organization that makes a positive contribution to the lives of our employees, customers, patients, and the scientific community.
As the exclusive representative of the Amoy Diagnostics company for Serbia and Montenegro, we offer domestic healthcare institutions products and services of molecular diagnostics.
At the moment, we have the following products registered in the Agency for Medicines and Medical Devices:
AmoyDx KRAS/NRAS Mutation Detection Kit
AmoyDx Circulating DNA Kit
AmoyDx KRAS Mutation Detection Kit
AmoyDx EGFR/ALK/ROS1 Mutation Detection Kit
AmoyDx EGFR 29 Mutation Detection Kit
AmoyDx KRAS/NRAS/BRAF Mutation Detection Kit
AmoyDx NRAS Mutation Detection Kit
Super-ARMS EGFR Mutation Detection Kit
Super-ARMS EGFR T790M Mutation Detection Kit
Amoy Dx offers superior molecular diagnostics products and services to healthcare providers, academic institutions and pharmaceutical companies.
The company has a rich portfolio of tests focused on mutation detection and gene expression measurement in FFPE cancerous tissue. The tests are based on a proprietary real-time PCR technology called ADx-ARMS.
They are characterized by an outstanding sensitivity of 1% and an accuracy of 99%. The EGFR, EML4-ALK, ROS1, ALK/ROS1, KRAS 7, BRAF and PIK3CA assays have received both CE declarations for marketing in Europe as well as SFDA approval for clinical use in China.
The NRAS, KRAS 19, RET, EGFR/ALK/ROS1, KRAS/NRAS and KRAS/NRAS/BRAF tests are CE marked for diagnostic (IVD) use in Europe.
The tests are designed and tested in a laboratory that is certified according to the ISO-13485 standard, and they are made in a dedicated factory whose production process is in accordance with good manufacturing practices (GMP). The tests are easy to perform, provide results within 90 minutes, and have been shown to be valid on several PCR instruments commonly used in diagnostic laboratories.
AmoyDx supplies EGFR tests to AstraZeneca in China. Amoy Diagnostics and AstraZeneca are working closely together to advance the growth of molecular diagnostic testing for lung cancer patients in the interior of the People’s Republic of China.
AmoyDx also supplies ROS1 assays for pivotal clinical trials of Pfizer’s crisonitib in China, South Korea and Japan.
Headquartered in beautiful Xiamen, China, Amoy Dx is a privately held, well-funded company with a rich and growing portfolio of products under development in the field of molecular diagnostics.
Our mission is to become a leading global supplier of high-quality diagnostic products.
We achieve this mission by:
1. we adhere to the strictest manufacturing standards with the aim of offering quality products at competitive prices;
2. we maintain an unsurpassed level in servicing needs and creating client satisfaction;
3. we work on scientific innovations while supplying customers with practical pioneering technologies and value-added products;
4. we are creating a world-class organization that makes a positive contribution to the lives of our employees, customers, patients, and the scientific community.
Amoy Dx: Informacije: office@sineksmedical.com
tel: 011 450 88 66