Personalis secured CE-IVD marking for its blood collection kits used with its ultrasensitive NeXT Personal minimal residual disease assay. The kits—EDTA and cfDNA collection formats—now permit marketing and sales in the EU under the In Vitro Diagnostic Regulation. Personalis said the milestone helps standardize the pre-analytical phase of testing, improving consistency for genomic analysis and enabling broader deployment in clinical trials. The company linked the CE-IVD designation to scaling MRD testing for oncology studies that rely on high sensitivity across sample handling conditions. The news comes as Personalis continues expanding commercialization for NeXT Personal, including Medicare coverage previously granted for specific breast cancer and immunotherapy monitoring settings. CE-IVD marking adds another layer of regulatory readiness for multi-region adoption.