What is CellDx-Tissue?

CellDx-Tissue is a comprehensive genomic profiling test that provides tumour mutation information for qualified healthcare professionals.

Deep DNA and RNA sequencing across 517 genes identifies single-nucleotide variants, insertions and deletions, ERBB2 amplification, and ALK, RET and ROS1 fusions.

Designed for Precision Oncology Workflows

• Personalised Care: Identifies genetic changes driving each patient’s cancer.
• Strategic Clarity: Supports confident decisions through deeper tumour biology.
• Advanced Opportunities: Connects findings with targeted treatments and trials.
• Timely Results: Provides clinically useful insights for treatment planning.

The Next Generation of Personalised Medicine

• True Multi-omic Depth: Integrated DNA and RNA sequencing captures variants and fusions that DNA-only panels may miss.
• Sample Efficiency: Reliable performance with low-input tissue samples.
• Integrated Clinical Insights: Harmonised genomic and clinical interpretation in one decision-ready report.

Clinical Depth at Every Step

• First-line selection using US FDA-approved targeted therapies.
• Refractory management through secondary-driver and pathway analysis.
• Resistance insights explaining why current treatment may have stopped working.
• Immunotherapy guidance using integrated TMB and MSI status.*
• Phase I–III clinical-trial matching based on the molecular profile.

*Offered as part of LDT services.

Multi-Biomarker Analysis

US FDA-Cleared Scope

• Single- and multi-nucleotide variants.
• Insertions and deletions.
• ERBB2 amplification.
• RNA-based ALK, RET and ROS1 gene fusions.

Supplementary Biomarkers

TMB, mismatch repair deficiency, homologous recombination deficiency and PD-L1 expression.

Why RNA-Based Fusion Testing Matters

DNA testing identifies many genetic changes, but some important gene fusions may be missed. RNA sequencing improves fusion detection and may reveal additional treatment opportunities.

Published literature suggests that integrating RNA-based sequencing can increase detection of actionable fusions by approximately 20% across solid tumours.

From Sample to Strategy

1. Sample collection: FFPE tumour tissue or biopsy.
2. DNA and RNA extraction: High-quality nucleic-acid isolation.
3. NGS sequencing: Deep sequencing across 517 genes.
4. Bioinformatics: Identification and classification of alterations.
5. Actionable reporting: Structured clinical-significance reporting.

References

1. Gai L, et al. Molecular characterization of oncogenic gene fusions in a large real-world cohort of solid tumours. Cancer Research Communications. 2025.
2. Michuda J, et al. Use of clinical RNA sequencing in detection of actionable fusions compared with DNA sequencing alone. 2022.
3. Jin G, et al. Superiority of targeted RNA sequencing for fusion detection and subtype diagnosis in sarcoma. Experimental Hematology & Oncology. 2025.