Amoy Diagnostics Co., Ltd.

Company Description

Amoy Diagnostics provides state-of-the-art molecular diagnostic products and services to healthcare providers, academic institutions, and pharmaceutical companies. The company has a rich portfolio of tests that focuses on detecting mutations and measuring gene expression in FFPE cancer tissue.

The assays are designed and tested in an ISO-13485 certified laboratory and assembled in a dedicated GMP-compliant manufacturing plant.  In addition to the EGFR, KRAS and BRAF tests, the company has kits for detecting mutations in JAK2, KIT, BCR-ABL, PIK3CA, EML4-ALK, P53 and the RET oncogene. Quantitative gene expression assays for excision repair (ERCC1), thymidine phosphorylase (TYMP), stathmin (STMN1), ribonucleotide reductase (RRM1) and other genes provide valuable information to help predict chemotherapy responses.

 

The assays are easy to perform, provide results in 90 minutes, and have been validated on several PCR  instruments that are commonly used in diagnostic laboratories.

AmoyDx supplies EGFR tests to AstraZeneca in China.  ROS1 tests for pivotal clinical trial of Pfizer´s crizotinib in China, Korea, and Japan.

 

Located in beautiful Xiamen, China, Amoy Diagnostics is a privately held, Amoy Diagnostics Co., Ltd.ll-financed company with a rich and growing pipeline of molecular diagnostic products. Our mission is to be a leading global supplier of high quality diagnostic products.

We will accomplish this mission 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 our 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, and the scientific community.

The EGFR, KRAS, BRAF, PIK3CA  EML4-ALK and ROS1 tests are approved for clinical use in China and are CE marked for IVD use in Europe.  assays are CE marked for IVD use in Europe. Any other use of the assays is for research purposes only.