CMS expanded Medicare coverage for Personalis’ NeXT Personal minimal residual disease test to include monitoring response to neoadjuvant therapies in stage II to III triple-negative or HER2-positive breast cancer. The coverage decision was supported by evidence from the PREDICT-DNA prospective clinical study and represents the fourth Medicare coverage decision for the whole-genome sequencing-based, tumor-informed assay. Personalis framed the decision as an escalation from earlier coverage used for immunotherapy monitoring and recurrence surveillance into active treatment management. The company’s stock reaction reflected investor focus on reimbursement-driven expansion as MRD testing becomes increasingly integrated into oncology clinical pathways. —
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