Personalis, Inc. announced today that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the NeXT Personal test. This decision supports immunotherapy monitoring for patients with late-stage solid tumors. NeXT Personal is a minimal residual disease (MRD) test. It is the first such test to receive pan-cancer coverage for this specific clinical use. The technology leverages whole-genome sequencing to track up to approximately 1,800 patient-specific mutations.
The coverage enables Medicare beneficiaries to access ultrasensitive testing to monitor treatment response. This applies to patients receiving immunotherapy for any solid tumor. By tracking tumor dynamics, the test identifies molecular responders ahead of traditional imaging. This milestone validates the strategy of moving the platform into active treatment management. The approval ensures clinicians have a high-resolution view of a patient’s unique tumor profile.
“Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer. This decision validates our strategy of moving NeXT Personal into the heart of active treatment management. For the first time, Medicare patients on immunotherapy will have an ultrasensitive MRD test to help their doctors see if a treatment is working in real-time,” said Chris Hall, CEO of Personalis.
High-Resolution Insights for Advanced Cancer Management
The test provides a molecular signal of true disease burden during therapy. This is particularly useful when inflammatory responses complicate the interpretation of traditional scans. This clinical phenomenon is known as pseudoprogression. The test offers a clear view of how a patient’s cancer responds to modern drugs. These insights help physicians and patients understand treatment progress with more precision.
“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,” said Dr. Richard Chen, Chief Medical Officer at Personalis.
Medicare patients on immunotherapy can now access this ultrasensitive MRD test in real-time. This coverage is underpinned by clinical evidence generated with the Vall d’Hebron Institute of Oncology (VHIO). Personalis continues to transform the active management of cancer through personalized testing. The company remains committed to driving a new paradigm throughout the patient journey. These advancements aim to optimize therapeutic pathways and manage healthcare costs. This decision represents a major achievement for the oncology community.
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News Source: Businesswire.com
