Personalis Inc. (NASDAQ: PSNL) announced that the Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program has expanded coverage for its NeXT Personal minimal residual disease test to include monitoring treatment response to neoadjuvant therapy in patients with Stage II-III Triple-Negative Breast Cancer or HER2-positive breast cancer.

This marks the company's fourth Medicare coverage decision for NeXT Personal. Previous coverage enabled post-surgical recurrence surveillance, while the new determination extends Medicare coverage to the neoadjuvant setting, allowing clinicians to monitor therapy effectiveness before surgery.

The coverage decision is supported by clinical evidence from the PREDICT-DNA study, published in the Journal of Clinical Oncology. The prospective study followed 227 patients with TNBC and HER2+ breast cancer across more than 24 U.S. cancer centers. The study demonstrated that ultrasensitive ctDNA monitoring with NeXT Personal allows tracking of neoadjuvant therapy response and outperforms traditional clinical metrics in predicting patient outcomes.

The study found that nearly half of all ctDNA detections following neoadjuvant therapy occurred at levels below 100 parts per million, which the company states are low-level traces that less sensitive tests can miss.

"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.

NeXT Personal can track up to approximately 1,800 patient-specific variants, according to the company. The test is designed to detect minimal residual disease and recurrence at early timepoints and enable selection of targeted therapies based on genomic profiling.