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The FDA-approved comprehensive genomic profiling test will be reimbursed at a rate of $2,989.55 per test, helping to advance adoption in the US healthcare system
Illumina, Inc. (NASDAQ: ILMN) today announced that reimbursement has been granted for its FDA-approved in vitro diagnostic (IVD) TruSight™ Oncology (TSO) Comprehensive test. The reimbursement decision from the Centers for Medicare and Medicaid Services (CMS) will expand access to comprehensive genomic profiling (CGP) and the growing role of personalized genomics in oncology 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.
TSO Comprehensive gives clinicians the ability to simultaneously assess hundreds of 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.
TSO Comprehensive enables laboratories of all sizes to deliver FDA-approved, clinically valuable genomic insights that are easy to access and implement. This promotes broader access to precision oncology diagnostics across academic medical centers, healthcare networks, hospitals, and regional reference laboratories.
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.
Advancing clinical genomics across the healthcare ecosystem
Clinical demand for genomic testing is growing at every level of the health care ecosystem. With that demand comes opportunity for better health care and improved quality of life by advancing access to and adoption of tests like TSO Comprehensive.
Earlier this month, Illumina reported preliminary unaudited financials for the fourth quarter and fiscal year 2025, which highlighted clinical markets as a key driver of growth. Roughly 60% of the company's sequencing consumables revenue was driven by clinical customers last year.
About TruSight Oncology Comprehensive
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).
Use of forward-looking statements
This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) customer uptake of, and satisfaction with, new and existing products and services; and (ii) our ability to obtain or maintain regulatory approval for our products from government agencies and reimbursement from payors, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.
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SOURCE Illumina, Inc.
