Amoy Diagnostics, China, Expands List of CE-marked Real-Time PCR Kits for Cancer Diagnostics

GÖTTINGEN, Germany - Oct. 22, 2014 - PRLog -- Amoy Diagnostics, headquarted in Xiamen, China, 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%).

The  following kits already have been approved for CE-IVD in Europe and CFDA for clinical use in China:

• EGFR

• KRAS

• BRAF

• PIK3CA

• EML4-ALK

• ROS1

• ALK/ROS1

Just recently also the  followings kits have been approved for CE marking as well.

• NRAS

• KRAS/NRAS

• RET

• ERCC1

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 above tests, the company has kits for detecting mutations in JAK2, C-KIT, BCR-ABL, MEK1 and HER2 oncogene. Quantitative gene expression assays for excision repair (ERCC1), thymidylate synthase (TYMS), 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.

MoBiTec GmbH, located in Goettingen, Germany, is proud of being one of the members of the prestigious Amoy Diagnostics distributors' family.