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艾德生物 AmoyDx 
厦门艾德生物医药科技有限公司成立于2008年,由“千人计划”国家特聘专家郑立谋博士创办,是专业化的肿瘤个体化分子诊断产品研发生产企业
艾德生物已研发出20余种肿瘤个体化分子诊断产品,其中EGFR、KRAS、BRAF、EML4-ALK、PIK3CA五种肿瘤分子诊断领域最重要的基因变异检测试剂产品率先获得CFDA《医疗器械注册证》和欧盟CE认证。产品所需组织量低、操作简便、灵敏度高、易于标准化,真正实现了“多重基因,一次检测”。依靠雄厚的研发实力、优越的产品性能,艾德生物与海峡两岸数十家知名医院,阿斯利康、辉瑞等跨国生物制药企业建立了战略合作关系,产品远销40余个国家和地区。


Dedicated to precision oncology, Amoy Diagnostics Co., Ltd. (AmoyDx) provides state-of-the-art molecular diagnostic products and services to various customers including but not limited to healthcare providers, academic institutions and pharmaceutical companies. AmoyDx has a rich portfolio of test kits that mainly focuses on oncology target therapy companion diagnostics.

 


All our products are developed in an ISO-13485 certified laboratory and assembled in a GMP-compliant manufacturing plant. A proprietary real-time PCR technology, called ADx-ARMS which has outstanding sensitivity (1%) and accuracy (99%), is used for majority of PCR-based products. AmoyDx tests are easy to perform, providing results in 1.5-2.5 hours and have been validated on different types of real-time PCR instruments commonly used in diagnostic laboratories.

 


AmoyDx has been diagnostic partner of several major pharmaceutical companies such as AstraZeneca and Pfizer, for personalized healthcare in various regions. Of note, AmoyDx ROS1 fusion detection kit has been used as companion diagnostic test for pivotal clinical trial of Pfizer’s Crizotinib in China, Japan and Korea.

 


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.
 

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