CellDx Tissue CellDx Tissue

Understanding What Drives Cancer to Help Guide Personalized Treatment

Comprehensive DNA + RNA Insights for Precision Oncology

India's only US FDA-cleared genomic profiling assay

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Overview

CellDx-Tissue is a comprehensive genomic profiling test that provides tumour mutation profiling information intended for use by qualified healthcare professionals in accordance with professional guidelines. By integrating deep genomic sequencing of 517 genes, it enables a detailed understanding of an individuals cancer through its genetic makeup. The test Identifies somatic genomic alterations including single nucleotide variants, insertions and deletions, ERBB2 gene amplification, and fusions in ALK, RET, and ROS1.

Designed for Precision Oncology Workflows

Transforming Cancer Care Through Personalized Insights

Personalized Care

Discover the genetic changes driving each patient's cancer to support informed clinical decision-making by qualified healthcare professionals.

Strategic Clarity

Understand tumour 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 Multi-omic 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 US 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

*Offered as part of LDT services

Trial Matching

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

MultiBiomarker Analysis

Enabling a Deeper Understanding of tumour Biology

US FDA-Cleared Scope

  • Single-Nucleotide Variants (SNVs)
  • Multi-nucleotide Variants (MNVs)
  • Insertions & Deletions (Indels)
  • RNA-based Gene Fusions (ALK, RET, ROS1)

Supplementary

  • Tumour 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 under CLIA-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.
Published literature suggests that integrating RNA-based sequencing can increase detection of actionable fusions by ~20% across solid tumours (1, 2, 3).

From Sample to Strategy: The CellDx-Tissue Journey

Sample Collection

FFPE tumour 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-accredited and CLIA-certified laboratory

Bioinformatics Analysis

Advanced Algorithms identify and classify genomic alteration

Actionable Reporting

Structured reporting of detected genomic alterations and their clinical significance classification

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 tumour’s 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 therapies-treatments 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: Comprehensive, structured tumour mutation profiling to support the oncologist's next conversation
How is CellDx-Tissue ordered?
CellDx-Tissue can be ordered by oncologists or healthcare providers through the designated test requisition process or by contacting our support team.
What tumour 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 tumour biology and is suitable for molecular evaluation of solid tumours.
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 tumour 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: Detected genomic variants classified by clinical significance level, ERBB2 amplification status, and ALK/RET/ROS1 fusion status.
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 tumours. Cancer Research Communications. 2025 Nov 6;5(11):196776.
  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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