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Amoy Diagnostics Obtains CE Mark for Cancer Mutation Assays

NEW YORK (GenomeWeb) — Chinese molecular diagnostics firm Amoy Diagnostics said today that four of its mutation analysis kits have received CE marking.

The new kits are for mutation analysis in NRAS, KRAS/NRAS, RET, and ERCC1. The company already had CE-IVD-marked tests available for EGFR, KRAS, BRAF, PIK3CA, EML4-ALK, ROS1, and AK/ROS1.

Amoy's assays are designed to detect mutations and measure gene expression in formalin-fixed, paraffin-embedded cancer tissue. They are based on a proprietary real-time PCR technology called ADx-ARMS and have been validated on several commonly used PCR instruments, the company said.

Last week, Xiamen-based Amoy said that it had named Germany's MoBiTec as the distributor for its assays in that country.

The Scan

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