Personalis Inc Receives Medicare Coverage for Next Personal for Immunotherapy Monitoring Across Late-Stage Solid Tumors

Published: 2026-05-13 08:50:31 ET PSNL

Published on 05/13/2026 at 08:50 am EDT

Personalis, Inc. announced that the Centers for Medicare & Medicaid Services? Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company?s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for patients with late-stage solid tumors. This coverage determination is underpinned by landmark clinical evidence generated in collaboration with the Vall d?Hebron Institute of Oncology (VHIO).

The recently published study demonstrated that NeXT Personal?s ultrasensitivity allows for ongoing evaluation of treatment response and the prediction of clinical outcomes in patients undergoing immunotherapy. By tracking tumor dynamics, the test can identify molecular responders and non-responders ahead of traditional radiologic imaging. Immunotherapy has revolutionized cancer care, with several hundred thousand patients in the US receiving immunotherapy per year, yet treatment response remains variable.

Identifying which patients are responding and which are not is critical for optimizing therapeutic pathways, minimizing unnecessary toxicity, and managing the high costs associated with these advanced therapies. NeXT Personal leverages whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM). By tracking up to ~1,800 patient-specific mutations, the assay provides a high-resolution view of a patient?s unique tumor profile.

In the immunotherapy setting, where inflammatory responses can often complicate the interpretation of traditional scans (a phenomenon known as pseudoprogression), NeXT Personal provides a clear, molecular signal of true disease burden. The VHIO data shows that immunotherapy monitoring with a highly sensitive, quantitative test like NeXT Personal can help physicians and patients understand treatment response with more precision, including situations where imaging results can be ambiguous. This coverage gives physicians another tool for proactively managing immunotherapy.