Expansion of Medicare Coverage for Immunotherapy Monitoring

Personalis Inc has announced a significant expansion in coverage under the Centers for Medicare & Medicaid Services Molecular Diagnostic Services Program. This development extends to the NeXT Personal minimal residual disease (MRD) test, now covering immunotherapy monitoring for patients with advanced solid tumors. Backed by clinical evidence from a collaboration with the Vall d’Hebron Institute of Oncology (VHIO), the study highlights the test's ability to evaluate treatment responses and predict clinical outcomes effectively. This assay offers insights into tumor changes, distinguishing molecular responders before traditional imaging can.

With immunotherapy serving hundreds of thousands of patients annually in the United States, identifying responder patients accurately is crucial. This helps enhance care pathways, minimize unnecessary toxicity exposure, and manage treatment costs efficiently. Chris Hall, CEO of Personalis, remarked, "Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer." This achievement integrates NeXT Personal into treatment management, enabling Medicare patients receiving immunotherapy to validate treatment efficacy in real-time using an ultrasensitive MRD test.

The NeXT Personal test utilizes whole-genome sequencing and noise-suppression technology, providing sensitivity down to 1 part per million. By monitoring approximately 1,800 patient-specific mutations, it offers detailed insights into unique tumor profiles. Immunotherapy can sometimes result in ambiguous traditional scan results due to inflammatory responses, termed pseudoprogression. However, Personalis's assay provides an accurate molecular assessment of disease burden in these scenarios. Richard Chen, president and chief medical officer at Personalis, emphasized, "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, even when imaging results are unclear."