Personalis, Inc. (PSNL) announced that Medicare has expanded coverage for its NeXT Personal minimal residual disease (MRD) test, allowing late-stage solid tumor patients receiving immunotherapy to access ultrasensitive molecular monitoring. This expansion was issued through the Centers for Medicare & Medicaid Services' MolDX program.
The decision is supported by clinical evidence generated with the Vall d'Hebron Institute of Oncology (VHIO).
The newly published VHIO study showed that NeXT Personal's ultrasensitivity enables physicians to track tumor dynamics, evaluate treatment response and predict clinical outcomes during immunotherapy.
The study showed that NeXT Personal can track tumor dynamics and identify molecular responders and non-responders ahead of radiologic imaging, offering earlier insight into whether a therapy is working in real time. This is particularly valuable in immunotherapy, where inflammation and pseudoprogression can complicate scan interpretation.
Personalis noted that immunotherapy continues to grow across oncology, yet treatment responses vary widely. With several hundred thousand U.S. patients receiving immunotherapy each year, early identification of responders is critical for optimizing treatment pathways and minimizing unnecessary toxicity.
"Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer," said Chris Hall, CEO of Personalis, adding that the decision validates the company's strategy of integrating NeXT Personal into active treatment management.
NeXT Personal uses whole-genome sequencing and advanced noise-suppression technology to detect tumor signals at extremely low levels, achieving sensitivity down to 1 part per million and tracking up to ~1,800 patient-specific mutations. This high-resolution molecular view helps distinguish true disease progression from immune-related imaging artifacts such as pesudoprogression.
PSNL has traded between $3.84 and $11.50 over the past year. The stock is currently trading at $7.22, up 19.47%.
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