The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989 per test, effective Jan. 1, 2026, Illumina announced. The decision covers an FDA‑approved comprehensive genomic profiling (CGP) test that interrogates >500 genes and supports treatment decisions in solid tumors, including companion‑diagnostic claims for NTRK and RET fusions. CGP tests analyze large gene panels to match patients with targeted therapies and clinical trials. CMS reimbursement removes a major barrier to adoption in community oncology settings and may accelerate uptake of tissue‑based CGP in standard‑of‑care workflows. Illumina cited the payment decision as a step to expand precision oncology access. The reimbursement could influence payer conversations for other broad genomic assays and alter provider adoption patterns; it also sets a precedent on valuation for high‑complexity, oncology‑focused molecular diagnostics.
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