The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay under PLA code 0543U at $2,989.55 per test, effective Jan. 1, 2026. The FDA‑approved comprehensive genomic profiling test covers more than 500 genes and is intended to inform targeted therapy selection in solid tumors, including clinically actionable fusions and splice variants. Illumina framed the decision as removing a barrier to adoption of comprehensive genomic profiling in clinical care; broader reimbursement could accelerate uptake of CGP in oncology clinics and impact companion diagnostic strategies and patient enrollment in biomarker‑driven trials.
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