The US Centers for Medicare and Medicaid Services has granted Illumina reimbursement for its TruSight Oncology Comprehensive assay, the company said on Tuesday.

The US Food and Drug Administration-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per test using Proprietary Laboratory Analysis code 0543U, effective Jan. 1, 2026. The test interrogates more than 500 genes in solid tumor tissue to inform treatment decisions. It looks for single nucleotide variants, multi-nucleotide variants, insertions, and deletions using DNA, as well as fusions in 24 genes and splice variants in one gene using RNA.

“This decision helps remove barriers that have limited adoption of comprehensive genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes,” John Fox, Illumina’s senior director of market access and government affairs, said in a statement.

TSO Comprehensive is FDA approved as a companion diagnostic to determine which adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions may benefit from treatment with Bayer’s Vitrakvi (larotrectinib).

The test is also approved to identify adult patients with locally advanced or metastatic rearranged-during-transfection (RET) fusion-positive non-small cell lung cancer who could benefit from treatment with Lilly’s Retevmo (selpercatinib).