NEW YORK — Genetron Health said on Thursday that it has received CE marking for its Onco PanScan genomic profiling test for cancer.
The test uses next-generation sequencing and hybridization capture to detect cancer-linked mutations and variants covering more than 800 genes in order to guide patient treatment and provide cancer risk assessment screening. The gene list includes those recommended by the World Health Organization, National Comprehensive Cancer Network, and European Society for Medical Oncology, the company said.
"In China, Onco PanScan is a key [laboratory-developed test] for us, and we are preparing to start our IVD registrational trial shortly," Sizhen Wang, cofounder and CEO of Genetron Health said in a statement. "Genetron continues to grow all our business lines spanning early screening to diagnosis and monitoring."
In July, Beijing-based Genetron received the CE mark for its eight-gene lung cancer sequencing assay.