Amoy Diagnostics, China, Expands List of CE-Marked Real-Time PCR Kits for Cancer Diagnostics
Summary
Göttingen, Germany, October 24, 2014 --( The assays are based on a proprietary real-time PCR technology called “ADx-ARMS.” They have outstanding sensitivity (1%) and accuracy (99%).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.MoBiTec GmbH, located in Goettingen, Germany, is proud of being one of the members of the prestigious Amoy Diagnostics distributors family.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• RET• ERCC1Just recently also the followings kits have been approved for CE marking as well:• NRAS• KRAS/NRAS panelThe assays are designed and tested in an ISO-13485 certified laboratory and assembled in a dedicated GMP-compliant manufacturing plant.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.