MoBiTec, Germany, and Amoy Diagnostics, China, Sign Distribution Agreement for the German Market

GÖTTINGEN, Germany - Oct. 16, 2014 - PRLog -- 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 based on a proprietary real-time PCR technology called “ADx-ARMS”. They have outstanding sensitivity (1%) and accuracy (99%). EGFR,  KRAS, BRAF, PIK3CA and EML4-ALK tests have received both CE declarations for marketing in Europe and SFDA approval for clinical use in China, ROS1 and ERCC1 assays are CE marked for IVD use in Europe.

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. Amoy Diagnostics and AstraZeneca work closely together to foster the growth of molecular diagnostic testing for lung cancer patients in mainland China.

AmoyDx also supplies 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, well-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.

Amoy Diagnostics accomplishes 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 its employees and customers, and the scientific community.

Note: The EGFR, KRAS, BRAF, PIK3CA and EML4-ALK and ROS1 tests are approved for clinical use in China and are CE marked for IVD use in Europe. ROS1 and ERCC1 assays are CE marked for IVD use in Europe. Any other use of the assays is for research purposes only.

MoBiTec is proud to be representing Amoy Diagnostics in Germany!