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Shuwen Biotech Gets CE-IVD Mark for EGFR Mutation Kit

NEW YORK (GenomeWeb) – Shuwen Biotech announced today that it has received CE-IVD marking for its real-time PCR-based EGFR detection kit for lung cancer.

According to the company, the kit detects 29 mutations in exons 18, 19, 20, and 21, and has a limit of mutation detection at .1 percent in a background of wild-type DNA. It also contains lyophilized reagents that can withstand at least 12 freeze/thaw cycles.

With the CE-IVD marking, the kit is now approved for sale throughout the European Economic Area.

The company said it is also using its CODAR-PCR technology to finalize the development of other diagnostics such as a liquid biopsy test for EGFR, and BRAF, ALK, and ROS1 mutation detection assays.