Xiamen Spacegen Receives CE Marking for Six Molecular Testin

Xiamen Spacegen, a provider of oncology molecular diagnostics products and services in China, said recently that it had received CE marking for six testing kits.

These kits include a human thyroid carcinoma RET gene fusions detection kit, which is run on a multiplex fluorescence PCR platform; a human MGMT gene methylation detection kit, also run on multiplex fluorescence PCR; and a human EGFR gene T790M mutation detection kit, based on digital PCR technology.

The company also garnered CE marking for three tests based on high-throughput sequencing: a human pharmacogenomics SNP detection kit; a human radiotherapeutic side effect-related gene SNP detection kit; and a cardiotoxicity prediction of breast cancer detection kit.

Spacegen said that these new approvals mean it now has 11 products with CE marking, including kits for multi-gene mutations, BRCA mutations, EGFR mutations, KRAS mutations, and BRAF mutations. The firm also noted that it has applied for CE certification for additional products that it has developed.