Ultrasensitive MRD Assay Gains Medicare Coverage for Immunotherapy and Breast Cancer Monitoring

Personalis, Inc. reported expanded Medicare coverage for NeXT Personal for immunotherapy monitoring in patients with late-stage solid tumors. The company also received Medicare coverage approval for NeXT Personal to monitor treatment response to neoadjuvant therapy in patients with Stage II–III triple-negative breast cancer or HER2-positive breast cancer. With these additions, Medicare coverage for NeXT Personal now spans four indications.

NeXT Personal is part of a personalized testing approach designed for active cancer management. Personalis describes its assays as combining tumor-and-normal profiling with proprietary algorithms to provide insights as cancer evolves over time. The products are designed to detect MRD and recurrence at early timepoints, support targeted therapy selection through ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development.

Recent research findings cited by Personalis included the prospective VICTORI study led by the University of British Columbia. In that study, NeXT Personal detected 100% of patient relapses, including distant metastases in regions described as historically difficult to detect, such as the lung. Four weeks after surgery, the test detected more than 80% of patients who later relapsed, providing an early cancer signal to inform treatment pathways.

Personalis also highlighted findings from the TRACERx study in lung cancer. Approximately 21% of pre-operative adenocarcinoma detections and 18% of post-operative landmark detections were below 10 parts per million, thresholds described as frequently missed by less sensitive assays. Patients detected in that range had a three-fold increased risk of recurrence compared with patients with undetectable circulating tumor DNA.

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