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FDA-approved companion diagnostic

TruSight Oncology Comprehensive

Hybrid-capture NGS assay that profiles DNA and RNA from FFPE solid tumors to detect multiple genomic alterations and signatures for pan-cancer biomarker assessment.

IVD-developed CDxMethod: NGSSpecimen: Tissue (FFPE)Biomarker: Multiple genomic alterations
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Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P230011
Supplements
Manufacturer
Illumina, Inc.
Approval date
August 21, 2024
Test specifications
Methodology
NGS
Specimen
Tissue (FFPE)
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
What this test is

TruSight Oncology Comprehensive is a hybrid-capture, next-generation sequencing assay that analyzes DNA and RNA from FFPE solid tumors. It detects substitutions, insertions, deletions, copy number changes, and gene fusions across a broad set of cancer-related genes, and can report selected genomic signatures such as MSI or TMB to support comprehensive biomarker-driven treatment planning.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Non-Small Cell Lung Cancer (NSCLC)RETfusionsRETEVMO
Solid TumorsNTRK1, NTRK2 and NTRK3fusionsVITRAKVI

IVD Manufacturer

Illumina, Inc.

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on XFacebookLinkedInInstagramTikTok, and YouTube.

Order this test

If your organization is connected to Casandra, you can place an electronic order forTruSight Oncology Comprehensive directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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