{"entity":{"id":"trusight-oncology-comprehensive","kind":"drug","name":"TruSight Oncology Comprehensive","aka":[],"tldr":"A large gene panel hospitals can run themselves, approved by the FDA in 2024 as a companion diagnostic for the tumour-agnostic drug larotrectinib.","summary":"Illumina's TruSight Oncology Comprehensive is a kit-based, distributable comprehensive genomic profiling test, CE-IVD marked in Europe in 2022 and approved by the FDA in August 2024 with a companion claim for NTRK fusions (larotrectinib) alongside tumour-profiling claims. Unlike send-out services such as FoundationOne CDx, the test is run locally, which shortens turnaround and keeps data in the hospital. It reports tumour mutational burden and microsatellite status, so it also serves the tissue-agnostic pembrolizumab indications, and Illumina has filed additional companion claims.","status":"approved","asOf":"2026-09-10","links":[{"label":"Illumina: TruSight Oncology Comprehensive (page moved; nearest live section)","url":"https://www.illumina.com/products/by-type/clinical-research-products/"}],"tags":["test"],"related":[],"cancers":["pancreatic","colorectal"],"sections":[],"technologies":["cgp","companion-diagnostic"],"targets":["ntrk"],"drugs":["larotrectinib"],"companies":["illumina"],"institutions":[],"pathways":[],"terms":["ngs","tmb","msi"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: the report lists every actionable alteration found; the companion claim is currently for NTRK fusions, while the rest of the findings guide off-label or trial options."],"brand":"TSO Comprehensive","modality":"Distributable tissue NGS companion diagnostic test (500+ genes, DNA and RNA)","mechanism":"Hybrid-capture DNA and RNA sequencing of more than 500 genes on Illumina NextSeq instruments run in the hospital laboratory, reporting variants, fusions, tumour mutational burden and microsatellite instability.","approvals":[{"region":"EU","year":2022,"indication":"CE-IVD comprehensive genomic profiling"},{"region":"US","year":2024,"indication":"Companion diagnostic for larotrectinib (NTRK fusions) with tumour-profiling claims"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/trusight-oncology-comprehensive/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"tmb-testing","kind":"technology","name":"Tumour mutational burden testing","route":"/technologies/tmb-testing/"}],"target":[{"id":"ntrk","kind":"target","name":"NTRK","route":"/targets/ntrk/"}],"drug":[{"id":"larotrectinib","kind":"drug","name":"Larotrectinib","route":"/drugs/larotrectinib/"}],"company":[{"id":"illumina","kind":"company","name":"Illumina","route":"/companies/illumina/"}],"term":[{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"},{"id":"tmb","kind":"term","name":"Tumour mutational burden (TMB)","route":"/terms/tmb/"}],"biomarker":[{"id":"ntrk-fusion","kind":"biomarker","name":"NTRK1/2/3 gene fusion","route":"/biomarkers/ntrk-fusion/"},{"id":"ret-fusion","kind":"biomarker","name":"RET fusion and RET mutation","route":"/biomarkers/ret-fusion/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}