Guardant Health has won FDA approval for an upgraded liquid biopsy built to expand the clinical footprint of its Guardant360 test. The agency clearance covers a blood-based comprehensive genomic and epigenomic assay that Guardant says analyzes a 100-fold larger genomic footprint than the prior Guardant360 cDx, with the existing seven companion diagnostic indications transferring to the new version. Separately, Personalis reported expanded Medicare coverage for its NeXT Personal MRD assay, adding use for monitoring response to neoadjuvant therapy in stage II–III triple-negative or HER2-positive breast cancer. The coverage decision cites evidence from the PREDICT-DNA prospective study, marking another step toward MRD becoming part of treatment management. Together, the announcements underscore regulators’ continuing shift toward assay upgrades and expanded clinical use cases—moving molecular diagnostics deeper into treatment decision pathways rather than reserving them for narrower surveillance roles.