Personalis Inc. (NASDAQ: PSNL) announced that the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program has expanded coverage for its NeXT Personal minimal residual disease test to include immunotherapy monitoring for patients with late-stage solid tumors.

The coverage decision is based on clinical evidence from a collaboration with the Vall d'Hebron Institute of Oncology. The published study demonstrated that the test's sensitivity allows for evaluation of treatment response and prediction of clinical outcomes in patients undergoing immunotherapy.

The NeXT Personal test uses whole-genome sequencing and noise-suppression technology to achieve sensitivity down to 1 part per million. The assay tracks up to approximately 1,800 patient-specific mutations to provide tumor profiling.

"Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer," said Chris Hall, Chief Executive Officer of Personalis. "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."

The test is designed to track tumor dynamics and identify molecular responders and non-responders ahead of traditional radiologic imaging. In immunotherapy settings, where inflammatory responses can complicate scan interpretation through pseudoprogression, the test provides molecular signals of disease burden.

Personalis is a genomics company focused on precision oncology testing. The company is based in Fremont, California.