The U.S. Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test (PLA code 0543U), effective Jan. 1, 2026. The decision removes a key barrier to adoption of comprehensive genomic profiling (CGP) in routine care for oncology patients. TSO Comprehensive interrogates >500 genes and is FDA‑approved for multiple companion diagnostic uses, including NTRK and RET fusions. Illumina framed the CMS move as expanding access to precision oncology and enabling broader use of CGP to guide targeted therapies. The reimbursement is likely to accelerate hospital and lab uptake of high‑plex assays and could shift testing patterns toward centralized, reimbursed CGP versus multiple single‑gene tests.
Get the Daily Brief