Illumina expands clinical oncology portfolio unlocking new standard of care and access to precision therapies

Core Insights - Illumina has expanded its clinical oncology portfolio to enhance access to precision oncology therapies through comprehensive genomic profiling solutions [1][2][3] Group 1: Product Offerings - The TSO Comprehensive test is the first FDA-approved distributable comprehensive genomic profiling IVD kit with pan-cancer CDx claims, evaluating both DNA and RNA [3][9] - The Pillar oncoReveal® CDx is a new addition to Illumina's IVD portfolio, designed for detecting genetic variations in 22 genes for patients with solid tumors [6][12] Group 2: Market Access and Reimbursement - TSO Comprehensive is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS) and most commercial health plans, facilitating broader access for patients [5][7] - The oncoReveal CDx has also received nationwide Medicare coverage, ensuring availability of next-generation sequencing testing for over 66 million people in the US [7][6] Group 3: Clinical Integration - Illumina's TSO Comprehensive is being integrated into clinical practices across various healthcare settings, including community oncology care practices and academic medical centers [3][4] - UofL Health – UofL Hospital is the first to offer the TSO Comprehensive test to patients, highlighting the growing adoption of this technology [3][4] Group 4: Regulatory Approvals - The TSO Comprehensive test has received regulatory approval in Japan, indicating the company's efforts to expand its market presence internationally [5] - The oncoReveal CDx is FDA approved for use on the Illumina MiSeq Dx System, further solidifying Illumina's position in the clinical diagnostics market [12]