FDA Approves Illumina Cancer Biomarker Test - San Diego Business Journal
Illumina's TruSight Oncology Comprehensive test, approved by the FDA, profiles 517 genes to match cancer patients with targeted therapies or clinical trials, aiding in personalized treatment.
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The FDA approved Illumina's TruSight Oncology (TSO) Comprehensive Assay for NTRK-positive solid tumors and RET fusion-positive NSCLC, enabling personalized treatment. PreCheck Health Services offers it as SolidTumorCheck+. The assay profiles over 500 biomarkers, enhancing identification of actionable biomarkers and supporting clinical trial enrollment. It will begin shipping in 2024 and is reimbursable under CMS guidelines.
Illumina's TruSight Oncology Comprehensive, an FDA-approved IVD biomarker test kit, detects variants in 517 genes across nearly 30 solid tumor types, enabling personalized targeted therapies and faster treatment interventions within 4-5 days.
Illumina's TruSight Oncology Comprehensive test, approved by the FDA, profiles 517 genes to match cancer patients with targeted therapies or clinical trials, aiding in personalized treatment.
FDA approves Illumina's TruSight Oncology Comprehensive Assay, enabling PreCheck Health Services to offer SolidTumorCheck+, a pan-cancer companion diagnostic test with comprehensive genomic profiling of over 500 gene biomarkers, enhancing precision oncology and patient care.