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Personalis Secures Fourth Medicare Coverage Decision for NeXT Personal®, Expanding Breast Cancer Coverage to Pre-Surgical Treatment Monitoring
Personalis Secures Fourth Medicare Coverage Decision for NeXT Personal®, Expanding Breast Cancer Coverage to Pre-Surgical Treatment
About this update from Personalis, Inc.
[{"type":"text","content":"\nPersonalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test. The new coverage determination is for monitoring treatment response to neoadjuvant therapy (NAT) in patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC) or HER2-positive (HER2+) breast cancer.\n\n\nThis 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.\n\n\nThe coverage determination is underpinned by clinical evidence from the prospective PREDICT-DNA study, recently published in the Journal of Clinical Oncology (JCO). 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.\n\n\n\"Securing our fourth Medicare coverage decision for NeXT Personal is another milestone that moves our technology into active treatment management,\" said Chris Hall, Chief Executive Officer of Personalis. \"We are focused on enabling a better outcome for patients by using our ultrasensitive MRD technology to help guide decisions throughout their clinical journey.\"\n\n\nA key finding of the PREDICT-DNA study was the clinical necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Nearly half of all ctDNA detections following NAT occurred at levels below 100 parts per million (PPM)—low-level traces of cancer that less sensitive MRD assays can miss.\n\n\n\"The clinical data published in JCO clearly show that neoadjuvant monitoring benefits from a highly quantitative, ultrasensitive test to capture treatment response dynamics. NeXT Pe...