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Burning Rock, Stratipath, Genetron Receive CE Marks for Cancer Tests

NEW YORK – Burning Rock Biotech, Stratipath, and Genetron Holdings announced on Wednesday that their products for detecting cancer, for informing breast cancer prognosis, and for guiding treatment, have received CE marking.

Burning Rock said it has received CE marking for its OverC Multi-Cancer Detection Blood Test, a qualitative next-generation sequencing-based in vitro diagnostic test for detecting DNA methylation markers using cell-free DNA from human peripheral whole blood. The test is for the early detection and localization of multiple cancer types in individuals 45 to 75 years of age, the Shanghai-based company said.

Stockholm-based Stratipath said its AI-based Stratipath Breast software for the prognostic risk stratification of breast cancers has been CE-IVD marked. The software is for the analysis of digital histopathology whole-slide images stained with hematoxylin and eosin. According to the company, Stratipath Breast enables faster turnaround time than traditional molecular tests and provides new information at the point of diagnosis while reducing costs.

Genetron Holdings announced its FusionScan Plus Kit was CE marked. The kit is an integrated DNA and RNA next-generation sequencing-based assay for the simultaneous detection of multiple gene mutations and fusions with lower thresholds. Based on the firm's One-Step Seq Method, FusionScan Plus covers 29 tumor-related mutant genes and 40 fusion genes, Beijing-based Genetron said.