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A large gene panel hospitals can run themselves, approved by the FDA in 2024 as a companion diagnostic for the tumour-agnostic drug larotrectinib.
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.
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. Connects to NTRK.
1.TruSight Oncology Comprehensive slips into a pocket on NTRK.
| Region | Year | Indication |
|---|---|---|
| EU | 2022 | CE-IVD comprehensive genomic profiling |
| US | 2024 | Companion diagnostic for larotrectinib (NTRK fusions) with tumour-profiling claims |
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Query for this drug: (TITLE:"TruSight Oncology Comprehensive" OR ABSTRACT:"TruSight Oncology Comprehensive" OR TITLE:"TSO Comprehensive" OR ABSTRACT:"TSO Comprehensive") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about TruSight Oncology Comprehensive, not a curated reading list.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling, Triple-negative breast cancer (TNBC) and the tag test.
Shares RET fusion and RET mutation, Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling and the tag test.
Shares Companion diagnostics, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Triple-negative breast cancer (TNBC) and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Comprehensive genomic profiling, Pancreatic ductal adenocarcinoma and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Triple-negative breast cancer (TNBC), Colorectal cancer and the tag test.
Shares Companion diagnostics, Triple-negative breast cancer (TNBC), Pancreatic ductal adenocarcinoma and the tag test.