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MoBiTec to Distribute Amoy's MDx Products in Germany

NEW YORK (GenomeWeb) – MoBiTec today announced a deal for the distribution of Amoy Diagnostics products in Germany.

Based in Xiamen, China, Amoy provides molecular diagnostics products and services, including tests for detecting mutations and measuring gene expression in formalin-fixed, paraffin-embedded cancer tissue. Its assays are based on a proprietary real-time PCR technology dubbed ADx-ARMS. Its tests for EGFR, KRAS, BRAF, PIK3CA, and EML4-ALK are CE-marked for marketing in Europe and Chinese Food and Drug Administration-approved for clinical use in China. Its ROS1 and ERCC1 assays are CE-marked for IVD use in Europe.

MoBiTec said Amoy's assays are designed and tested in an ISO 13485-certified laboratory and assembled in a dedicated GMP-compliant manufacturing plant, and have been validated to run on several PCR platforms commonly used by diagnostic labs.

Amoy also has kits for detecting mutations in JAK2, KIT, BCR-ABL, PIK3CA, EML4-ALK, P53, and the RET oncogene.

Based in Göttingen, Germany, MoBiTec offers its own research tools for molecular and cell biology research and distributes products from other companies.

Financial and other terms of the agreement were not disclosed.