PSNL News & Events

Personalis announced that the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program has expanded coverage for the company's NeXT Personal minimal residual disease test. The new coverage determination is for monitoring treatment response to neoadjuvant therapy in patients diagnosed with Stage II-III Triple-Negative Breast Cancer or HER2-positive breast cancer. This decision marks Personalis' fourth Medicare coverage milestone for NeXT Personal, expanding the test's clinical use in breast cancer. While previous coverage enabled post-surgical recurrence surveillance, this new milestone extends Medicare coverage into the neoadjuvant setting, allowing clinicians to utilize NeXT Personal's ultrasensitive technology to actively monitor therapy effectiveness before a patient undergoes surgery. The coverage determination is underpinned by clinical evidence from the prospective PREDICT-DNA study, recently published in the Journal of Clinical Oncology. The study followed 227 patients with TNBC and HER2+ breast cancer across more than 24 leading US cancer centers. Data from that study demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal allows accurate tracking of neoadjuvant therapy response and outperforms traditional clinical metrics in predicting long-term patient outcomes.

Personalis 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.