Illumina Inc. announced on May 28, 2025, an expanded clinical oncology portfolio, introducing new solutions to advance precision oncology and improve the standard of care. TruSight™ Oncology (TSO) Comprehensive, the first and only FDA-approved test offering a distributable comprehensive genomic profiling (CGP) IVD kit with pan-cancer companion diagnostic (CDx) claims, is now covered under Medicare plans by the Centers for Medicare & Medicaid Services (CMS) and most commercial health plans.
UofL Health – UofL Hospital became the first Illumina customer to offer TSO Comprehensive to patients, and the IVD kit also received regulatory approval in Japan. This broad reimbursement and adoption enable clinicians to rapidly match cancer patients with targeted therapies by evaluating both DNA and RNA.
Additionally, Illumina is partnering with Pillar Biosciences to offer Pillar oncoReveal CDx, an IVD kit for detecting genetic variations in 22 genes for solid tumors, which is FDA approved on the Illumina MiSeq™ Dx System and has received nationwide Medicare coverage. This expansion significantly broadens access to critical biomarker testing and precision oncology solutions.
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