Personalis secures fourth Medicare coverage decision for NeXT Personal

Personalis (PSNL) 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.