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艾德生物 AmoyDx 
廈門艾德生物醫藥科技有限公司成立于2008年,由“千人計劃”國家特聘專家鄭立謀博士創辦,是專業化的腫瘤個體化分子診斷產品研發生產企業
艾德生物已研發出20余種腫瘤個體化分子診斷產品,其中EGFR、KRAS、BRAF、EML4-ALK、PIK3CA五種腫瘤分子診斷領域最重要的基因變異檢測試劑產品率先獲得CFDA《醫療器械注冊證》和歐盟CE認證。產品所需組織量低、操作簡便、靈敏度高、易于標準化,真正實現了“多重基因,一次檢測”。依靠雄厚的研發實力、優越的產品性能,艾德生物與海峽兩岸數十家知名醫院,阿斯利康、輝瑞等跨國生物制藥企業建立了戰略合作關系,產品遠銷40余個國家和地區。


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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