Personalis received CE-IVD marking for its EDTA and cfDNA blood collection kits in the European Union, enabling marketing and sale under the EU In Vitro Diagnostic Regulation. The kits are designed to preserve sample integrity for Personalis’ ultrasensitive MRD testing using the NeXT Personal assay. The company said the update helps support larger global clinical trials by standardizing the pre-analytical phase. Personalis noted that it recently obtained Medicare coverage for NeXT Personal in specific breast cancer settings and immunotherapy monitoring across late-stage solid tumors, linking regulatory and reimbursement momentum to broader clinical adoption. From a development standpoint, harmonizing sample collection and handling can reduce site-to-site variability, a common bottleneck for MRD assays that require high analytical sensitivity and reproducibility.