FREMONT, California, May 20, 2026
Personalis announced that the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program has expanded Medicare coverage for the company’s NeXT Personal minimal residual disease (MRD) test for patients with Stage II-III Triple-Negative Breast Cancer (TNBC) and HER2-positive breast cancer undergoing neoadjuvant therapy (NAT). The decision marks the company’s fourth Medicare coverage milestone for the personalized oncology platform and significantly broadens access to ultrasensitive circulating tumor DNA (ctDNA) monitoring before surgery. The new reimbursement pathway enables clinicians to use NeXT Personal to actively monitor how patients respond to therapy during treatment rather than waiting until after surgery for recurrence surveillance. The expansion strengthens the role of personalized genomic testing in oncology and positions Personalis more aggressively within the rapidly growing MRD diagnostics market.
The new coverage determination is backed by findings from the prospective PREDICT-DNA study, which was recently published in the Journal of Clinical Oncology. The multi-center study followed 227 patients with TNBC and HER2+ breast cancer across more than 24 major U.S. cancer centers and demonstrated that ultrasensitive ctDNA monitoring could accurately track patient response during neoadjuvant treatment while outperforming traditional clinical metrics in predicting long-term outcomes. According to the study, nearly 50% of ctDNA detections after therapy occurred below 100 parts per million, highlighting the importance of highly sensitive molecular testing capable of detecting extremely low residual disease levels that standard assays may miss. The findings reinforce the growing clinical demand for precision monitoring tools capable of detecting molecular relapse earlier and guiding personalized treatment decisions throughout the patient journey.
Ultrasensitive MRD Technology Targets Active Treatment Monitoring
Unlike conventional monitoring approaches focused primarily on imaging or pathology after surgery, NeXT Personal is designed to provide continuous molecular insight during active treatment. The platform tracks up to approximately 1,800 patient-specific tumor variants, enabling highly quantitative assessment of treatment response dynamics. This level of genomic resolution allows oncologists to identify whether therapy is effectively eliminating cancer cells or if residual disease persists despite treatment. In breast cancer settings where neoadjuvant therapy has become standard care, particularly for aggressive TNBC and HER2+ disease, the ability to measure response earlier could influence treatment escalation, therapy changes, or surgical planning.
Personalis executives emphasized that the expanded coverage pushes the company beyond recurrence surveillance and deeper into active clinical management. Chief Executive Officer Chris Hall stated that the company aims to improve patient outcomes by helping physicians make more informed treatment decisions through ultrasensitive MRD analysis. Chief Medical Officer Dr. Richard Chen noted that the quantitative sensitivity of NeXT Personal is essential for accurately capturing low-level ctDNA changes during therapy, especially because many residual disease signals fall below thresholds detectable by less advanced assays. The expanded Medicare support is expected to increase physician adoption of personalized MRD testing in breast cancer treatment workflows and accelerate the integration of genomic monitoring into routine oncology care.
Precision Oncology Market Continues Rapid Expansion
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The latest Medicare coverage decision also highlights the growing commercial and clinical momentum behind precision oncology diagnostics and personalized cancer monitoring technologies. MRD testing has become one of the most competitive areas in oncology diagnostics as companies race to develop assays capable of detecting cancer recurrence earlier, improving treatment selection, and supporting drug development strategies. Expanding reimbursement remains one of the most critical catalysts for market adoption, particularly in community oncology settings where payer coverage directly impacts testing utilization.
With this fourth Medicare milestone, Personalis strengthens its position in the evolving MRD landscape alongside other major genomic testing players pursuing broader reimbursement and clinical validation. The company’s strategy focuses on combining tumor-and-normal genomic profiling with proprietary bioinformatics algorithms to improve sensitivity and personalization. As healthcare systems increasingly move toward data-driven cancer management, coverage expansions like this are expected to accelerate demand for genomic monitoring platforms capable of guiding treatment decisions across the full continuum of cancer care. For breast cancer patients undergoing neoadjuvant therapy, the ability to access reimbursed ultrasensitive molecular testing before surgery could represent a major advancement in personalized oncology treatment management.
Source: Personalis, press release
