CellDx Tissue CellDx Tissue

Understanding What Drives Cancer to Help Guide Personalised Treatment

FDA-Cleared DNA + RNA Insights for Precision Oncology

Overview

CellDx-Tissue is a comprehensive molecular profiling solution designed to empower personalized cancer treatment strategies. By integrating deep genomic sequencing of 517 genes, it enables a detailed understanding of an individual’s cancer through its genetic makeup. The test identifies key molecular alterations driving the disease, along with potential targeted therapies and resistance mechanisms. This provides the clarity needed to navigate complex treatment decisions and supports more informed, individualized care.

Designed for Precision Oncology Workflows

Transforming Cancer Care Through Personalized Insights

Personalized Care

Discover treatment options tailored to the genetic changes
driving each patient’s cancer

Strategic Clarity

Understand tumor biology and behavior to guide confident and
informed decisions

Advanced Opportunities

Access emerging therapies, medical advances, and relevant
clinical trial opportunities

Timely Results

Results available within 5 business days, minimizing delays in
clinical decision-making

The Next Generation of Personalized Medicine

Bringing Precision, Depth, and Clarity to Cancer Care

True Multiomic Depth

Integrated DNA and RNA sequencing captures variants, including fusions often missed by DNA-only panels

Sample Efficiency

Reliable performance with low-input tissue samples, delivering consistent results even when sample quality is limited

Integrated Clinical Insights

Harmonized genomic and clinical interpretation combining multiple biomarkers into a unified, decision-ready report

Clinical Depth at Every Step

Precision Intelligence for Every Clinical Decision

First-Line Selection

Identifies FDA-approved targeted therapies for treatment-naive patients based on their tumor genomic profile

Refractory Management

Reveals secondary drivers and alternative pathways when standard therapies are no longer effective

Resistance Insights

Detects resistance-associated mutations that explain why current treatments have stopped working

Immunotherapy Guidance

Leverages integrated TMB and MSI status to support immunotherapy response assessment

Trial Matching

Matches patients to Phase I–III clinical trials based on their unique molecular profile

Multi–Biomarker Analysis

Enabling a Deeper Understanding of Tumor Biology

FDA–Cleared Scope

  • Single Nucleotide Variants (SNVs)
  • Multinucleotide Variants (MNVs)
  • Insertions & Deletions (Indels)
  • RNA-based Gene Fusions

Supplementary

  • Tumor Mutational Burden (TMB)
  • Mismatch Repair Deficiency Status
  • Homologous Recombination Deficiency Status
  • PD-L1 Expression (IHC-based)

Note: Supplementary biomarkers are reported as a professional laboratory services underCLIA-certified environment. These biomarkers have not been cleared by the US FDA.

Clinical Utility Clinical Utility

Why RNA-Based Fusion Testing Matters

While DNA testing identifies many genetic changes, some important gene fusions may be missed—RNA-based sequencing improves their detection, helping uncover additional treatment opportunities that might otherwise go unnoticed.
Studies indicate that integrating RNA-based sequencing can increase detection of actionable fusions by ~20% across solid tumors (1, 2, 3.)

From Sample to Strategy: The CellDx-Tissue Journey

Sample Collection

FFPE Tumor Tissue Or Biopsy Sample Collected For Analysis

DNA & RNA Extraction

High-Quality DNA And RNA Isolation For Comprehensive Profiling

NGS Sequencing

Deep Sequencing Across 517 Genes In a CAP/CLIA - Accredited Laboratory

BioinformaticsDx Analysis

Advanced Algorithms Map Genomic Alterations To Therapies And Clinical Evidence

Actionable Reporting

Clear, Prioritized Report Guiding Personalized Treatment Decisions

Frequently Asked Questions

What is Comprehensive Genomic Profiling (CGP)? ›
No two cancers are exactly alike. Comprehensive Genomic Profiling (CGP) is a laboratory test that analyzes a tumors genetic code to identify specific “driver” mutations responsible for cancer growth.
Why is CGP important in cancer treatment? ›
Traditional treatments like chemotherapy are often one-size-fits-all. CGP helps clinicians identify targeted therapiestreatments designed to specifically act on cancer-driving mutations—often enabling more precise and effective care with fewer side effects.
What can be expected from CellDx-Tissue testing? ›
  • No extra procedures: Uses tissue already collected during biopsy or surgery, avoiding additional invasive steps
  • Fast answers: Results are typically available within approximately one week, enabling timely clinical decisions
  • A clear path forward: Provides structured insights to support confident evaluation of the next treatment step
How is CellDx-Tissue ordered? ›
CellDxTissue can be ordered by oncologists or healthcare providers through the designated test requisition process or by contacting our support team.
What tumor types is CellDx-Tissue suitable for?
CellDx-Tissue evaluates hundreds of genes in a single assay, enabling a broader and more clinically meaningful understanding of tumor biology and is suitable for molecular evaluation of solid tumors.
How is CellDx-Tissue different from single-gene or hotspot testing? ›
CellDx-Tissue evaluates hundreds of genes in a single assay, enabling a broader and more clinically meaningful understanding of tumor biology compared to limited single-gene tests.
What is the turnaround time (TAT) for CellDx-Tissue? ›
Results are typically available within 5 business days from sample receipt.
Is CellDx-Tissue performed in an accredited laboratory? ›
CellDx-Tissue testing is conducted in a CAP-accredited and CLIA-certified laboratory, ensuring high standards of quality and reliability.
How are results reported? ›
Results are provided in a simplified, clinically intuitive report that includes: Approved therapy options, Genomic highlights, Actionable insights for treatment decisions, Clinical trial opportunities.
How can I access the test results? ›
Results are shared securely with the ordering clinician through designated reporting channels.
Who can I contact for support or queries?
For test ordering, sample requirements, or report-related queries, please contact our support team or your designated representative. Alternatively, you may reach us at: Email: [email protected] WhatsApp (Message only): +91 8806150150

References

  1. 1. Gai L, et al. Molecular characterization of oncogenic gene fusions in a large real-world cohort of solid tumors. Cancer Research Communications. 2025 Nov 6;5(11):1967–76.
  2. 2. Michuda J, et al. Use of clinical RNA-sequencing in the detection of actionable fusions compared to DNA-sequencing alone. (2022): 3077–3077.
  3. 3. Jin G, et al. Superiority of targeted RNA sequencing for fusion detection and subtype diagnosis in Chinese sarcoma patients: a multicenter study. Experimental Hematology & Oncology. 2025 May 14;14(1):70.
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