Personalis Lands Expanded Medicare Coverage for MRD Test: Immunotherapy Monitoring in Late-Stage Solid Tumors
The NeXT Personal assay can now be used to monitor treatment response and predict outcomes in Medicare patients on immunotherapy.
The Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded Medicare coverage for Personalis’s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring in patients with late-stage solid tumors.
The coverage expansion, announced May 13, is supported by clinical evidence from a study conducted with Spain’s Vall d’Hebron Institute of Oncology, which found the test can identify molecular responders and non-responders ahead of traditional radiologic imaging by tracking tumor dynamics.
“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,” Personalis CEO Chris Hall said in a statement.
The company’s NeXT Personal uses whole-genome sequencing to track approximately 1,800 patient-specific mutations.