By Diagnostics World Staff
January 21, 2026 | Illumina has announced CMS reimbursement for TruSight Oncology Comprehensive. The FDA-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per test. The news comes just a week after presenting a clinical-focused vision and strong Q4 results at the J.P. Morgan Healthcare Conference.
TruSight Oncology (TSO) Comprehensive is an invitro diagnostic test that gives clinicians the ability to simultaneously assess more than 500 genes—including relevant cancer biomarkers—to inform treatment decisions. With reimbursement now in place, more laboratories will be able to bring CGP in-house and deliver clinically actionable results to their patients, closer to the point of care.
"This decision helps removes barriers that have limited adoption of comprehensive genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes," said John Fox, MD, senior director, Market Access and Government Affairs at Illumina in a press release.
TruSight Oncology Comprehensive is a single FDA-approved test that interrogates more than 500 genes to profile a patient's solid tumor, helping increase the likelihood of identifying immuno-oncology or other clinically actionable biomarkers that can guide targeted therapy selection or clinical trial enrollment.
TSO Comprehensive is approved as a companion diagnostic (CDx) to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase (NTRK) gene fusions and 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 (NSCLC) who may benefit from treatment with Lilly's RETEVMO (selpercatinib).
Effective January 1, 2026, TSO Comprehensive is reimbursed under the Clinical Laboratory Fee Schedule at a rate of $2,989.55 using Proprietary Laboratory Analysis (PLA) code 0543U, which establishes a clear and predictable reimbursement pathway for all Medicare beneficiaries.