Personalis said CMS expanded Medicare coverage for its NeXT Personal minimal residual disease (MRD) test to include monitoring response to neoadjuvant treatment in patients with stage II to III triple-negative or HER2-positive breast cancer. The coverage decision is backed by evidence from the PREDICT-DNA prospective clinical study. The expanded coverage marks Personalis’ fourth Medicare coverage decision for NeXT Personal, a whole-genome sequencing-based, tumor-informed laboratory-developed assay. The company previously received coverage for immunotherapy monitoring in late-stage solid tumors and for recurrence monitoring across stages II to III breast cancer and stages I to III non-small cell lung cancer. Personalis positioned the update as a step toward active treatment management, with the company linking ultrasensitive MRD measurement to clinical decision-making across the care continuum.
Get the Daily Brief