The FDA-approved genomic profiling test will be reimbursed at $2,989.55 per test under Medicare, expanding access to precision oncology diagnostics.
Illumina Inc has secured reimbursement from the Centers for Medicare and Medicaid Services (CMS) for its TruSight Oncology (TSO) test, establishing a pathway for laboratories to offer the US Food and Drug Administration-approved genomic profiling test to Medicare beneficiaries.
Effective Jan 1, 2026, TSO is reimbursed under the Clinical Laboratory Fee Schedule at $2,989.55 per test using Proprietary Laboratory Analysis code 0543U. The reimbursement decision removes a key barrier that has limited adoption of genomic profiling in oncology care.
“This decision helps remove barriers that have limited adoption of genomic profiling for patients, empowering more healthcare providers to deliver precision oncology insights that will improve outcomes,” says John Fox, MD, senior director, market access and government affairs at Illumina, in a release.
Test Capabilities and Clinical Applications
TSO enables laboratories to simultaneously assess more than 500 genes to profile solid tumors, helping identify biomarkers that can guide targeted therapy selection or clinical trial enrollment. The test interrogates relevant cancer biomarkers to inform treatment decisions across various tumor types.
The test is approved as a companion diagnostic to identify adult and pediatric patients with solid tumors who are positive for neurotrophic tyrosine receptor kinase gene fusions and may benefit from treatment with Bayer’s VITRAKVI (larotrectinib). It also identifies adult patients with locally advanced or metastatic rearranged-during-transfection fusion-positive non-small-cell lung cancer who may benefit from treatment with Lilly’s Retevmo (selpercatinib).
Laboratory Market Impact
With reimbursement established, laboratories of all sizes can bring genomic profiling in-house and deliver results closer to the point of care. The decision is expected to promote broader access to precision oncology diagnostics across academic medical centers, healthcare networks, hospitals, and regional reference laboratories.
Clinical demand for genomic testing continues growing across the healthcare ecosystem. Earlier this month, Illumina reported that roughly 60% of the company’s sequencing consumables revenue was driven by clinical customers in 2025, highlighting clinical markets as a key growth driver.
The reimbursement establishes a predictable payment pathway for all Medicare beneficiaries receiving the test, potentially accelerating adoption among laboratories that previously faced uncertainty about coverage decisions.
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