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Illumina secures CMS reimbursement for TruSight™ Oncology Comprehensive, expanding access to precision oncology
Prnewswire· 2026-01-20 14:15
Core Insights - The FDA-approved TruSight™ Oncology Comprehensive test will be reimbursed at a rate of $2,989.55 per test, facilitating its adoption in the US healthcare system [1][6] - This reimbursement decision by the Centers for Medicare and Medicaid Services (CMS) aims to enhance access to comprehensive genomic profiling (CGP) and personalized genomics in oncology care [1][2] Group 1: Reimbursement and Access - The reimbursement for TSO Comprehensive will enable broader access to precision oncology solutions for patients with advanced cancer [2] - The decision removes barriers that have limited the adoption of CGP, empowering healthcare providers to deliver precision oncology insights that improve patient outcomes [3] - With reimbursement in place, more laboratories can implement CGP in-house, providing clinically actionable results closer to the point of care [4] Group 2: Clinical Impact and Market Demand - TSO Comprehensive allows clinicians to assess hundreds of genes, including relevant cancer biomarkers, to inform treatment decisions [4] - The test promotes broader access to precision oncology diagnostics across various healthcare settings, including academic medical centers and regional reference laboratories [5] - Clinical demand for genomic testing is increasing, presenting opportunities for improved healthcare and quality of life through enhanced access to tests like TSO Comprehensive [7] Group 3: Financial Performance - Illumina reported that approximately 60% of its sequencing consumables revenue in the previous year was driven by clinical customers, highlighting the importance of clinical markets for growth [8] - TSO Comprehensive is a single FDA-approved test that interrogates over 500 genes to profile solid tumors, increasing the likelihood of identifying actionable biomarkers for targeted therapy [9] Group 4: Companion Diagnostics - TSO Comprehensive is approved as a companion diagnostic to identify patients with specific gene fusions who may benefit from targeted therapies, such as Bayer's VITRAKVI® and Lilly's RETEVMO® [10]