Personalis received CE-IVD marking for its EDTA blood collection kit and cfDNA blood collection kit under the EU In Vitro Diagnostic Regulation, enabling marketing and sale in the region. The kits support sample integrity for the company’s ultrasensitive NeXT Personal assay, including minimal residual disease (MRD) testing. The milestone targets the often-overlooked pre-analytical step in genomics trials—standardizing collection so assay sensitivity can translate into consistent clinical performance. Personalis said Medicare coverage earlier this year for NeXT Personal supports adoption, while CE-IVD clearance helps expand the assay’s feasibility for global clinical evidence generation.