Personalis announces that CMS program expanded coverage for NeXT

Personalis (PSNL) announced that the Centers for Medicare & Medicaid Services’, or CMS, Molecular Diagnostic Services Program, or MolDX, has expanded coverage for the company’s NeXT Personal minimal residual disease, or 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, or 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, or PPM.