2025-07-29
We are pleased to share that SAGA Diagnostics, one of our portfolio companies, has achieved a significant regulatory milestone: the U.S. Medicare program now covers the Pathlight™ MRD (molecular residual disease) test for breast cancer across all subtypes.
This decision by Palmetto GBA’s MolDX program enables eligible Medicare beneficiaries to access the Pathlight test for recurrence monitoring in stages II–III breast cancer — including HR+/HER2-, HER2+, and triple-negative subtypes — for up to six years.
The coverage was granted following rigorous review of supporting evidence, including the TRACER study, which demonstrated Pathlight’s 100 % sensitivity and specificity, and a lead time of 13.7 months prior to detection of recurrence by standard-of-care methods.
This landmark coverage is a strong validation of SAGA’s technology and our shared mission to advance precision diagnostics. We believe it will accelerate adoption, broaden patient access, and strengthen SAGA’s commercial positioning in cancer diagnostics.
Link to Press Release