Oncomine Tumor Mutation Burden (TMB) Analysis – Precision Immuno-Oncology Genomic Profiling

Executive Summary & Core Performance Metrics

Clinical Executive Summary

Clinical Utility: High-depth next-generation sequencing (NGS) panel quantifying total somatic mutations per megabase to predict immune checkpoint inhibitor response and guide immuno-oncology treatment decisions.
Accuracy Guarantee: 99.9% diagnostic sensitivity achieved via ISO 9001:2015 certified NGS workflows, ensuring reproducible TMB scoring for solid tumor analysis.
Specimen Logistics: Secure Medical Courier Solid Tissue Specimen Retrieval – archived formalin-fixed paraffin-embedded (FFPE) tissue blocks or unstained slides are collected directly from your treating hospital or pathology laboratory via temperature-controlled courier.
Clinical Oversight: Results are correlated and reported in conjunction with a DHA-licensed specialist; multidisciplinary tumor board correlation is strongly advised for all treatment modifications.
Insurance & Billing: Direct insurance verification and billing support available via WhatsApp at +971 54 548 8731.

Test Overview & Methodology

The Oncomine Tumor Mutation Burden (TMB) assay is a comprehensive genomic profiling test performed on archived tumor tissue specimens. Using a targeted NGS panel covering over 400 cancer-related genes, the test calculates the total number of somatic coding mutations per megabase of the genome analyzed. A higher TMB score is associated with increased neoantigen burden and has been validated as a predictive biomarker for response to immune checkpoint inhibitors across multiple solid tumor types. The bioinformatics pipeline filters germline polymorphisms and sequencing artifacts to deliver a robust and reproducible TMB score aligned with global immuno-oncology standards.

Feature	Our Oncomine TMB Test	Closest Alternative
Precision	99.9% Diagnostic Sensitivity (ISO-accredited NGS)	Variable; often relies on older exome panels with lower uniformity
Methodology	Next-Generation Sequencing (NGS), Oncomine Comprehensive Panel v3	Targeted hotspot panels or whole-exome sequencing (longer turnaround)
Turnaround Time	14 – 21 Business Days	4 – 6 Weeks
Price	5,600 AED	Varies; often higher for similar coverage depth

Physician Insight & Clinical Safety Protocols

“TMB analysis provides a quantitative measure of genomic instability within the tumor microenvironment. In my practice, correlating high TMB scores with specific imaging features—such as tumor heterogeneity and metabolic activity on PET-CT—strengthens the clinical narrative for immune checkpoint inhibitor therapy. It is essential that TMB results are integrated with full histopathological and radiological assessment for personalized oncology decision-making.”

— Mr. Prabhakar Reddy Kalathoor | Specialist Diagnostic Radiology | DHA Registration ID: 61713011

Advisory: Medication & Treatment Continuity

⚠️ Important Medication Advisory: Do not discontinue, modify, or initiate any prescribed oncological therapy solely based on TMB results. All treatment decisions must be reviewed and approved by your attending oncologist or a qualified hematologist-oncologist.

Exclusion Criteria & Clinical Red Flags

Active severe infection or uncontrolled bleeding at prior biopsy site.
Inability to provide adequate tumor tissue (insufficient cellularity or necrosis exceeding 20%).
Known allergy to local anesthetics used during tissue collection.
ER Red Flags: Sudden severe pain, uncontrolled bleeding, or signs of infection post-biopsy require immediate medical attention.

Patient FAQ & Clinical Guidance

1. What is the Oncomine TMB test and how does it guide immunotherapy?

The Oncomine TMB test quantifies the total number of somatic mutations per megabase of tumor DNA. A high TMB score correlates with increased neoantigen generation, which can predict a favorable response to immune checkpoint inhibitors, such as anti-PD-1 and anti-PD-L1 therapies. Your oncologist uses this result alongside PD-L1 expression and MSI status to optimize treatment sequencing.

2. Why is the cost 5,600 AED and is it covered by insurance?

The cost reflects the advanced next-generation sequencing reagents, robust bioinformatics pipeline, and ISO 9001:2015 certified quality controls required for accurate TMB estimation. Many UAE health insurance policies partially or fully reimburse genomic profiling tests; our billing team performs direct verification via WhatsApp at +971 54 548 8731 to confirm your coverage.

3. How long until I receive my TMB results and how are they delivered?

The technical turnaround time is 14 to 21 business days from receipt of the FFPE tissue block or slides. Final results are uploaded to a secure, HIPAA-compliant online portal accessible by your referring physician. A mandatory telephonic post-test consultation with a DHA-licensed clinical specialist is scheduled to explain the clinical implications of your genomic report.

UAE Regulatory & Data Privacy Adherence

DNA Labs UAE strictly complies with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) and Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields. All genomic sequence data is encrypted, access-controlled, and processed exclusively under DHA Facility License 1143. Clinical safety, patient consent, and medical liability protocols are governed by Federal Decree-Law No. 4 of 2016 on Medical Liability. No raw genomic data is shared with third parties without explicit patient consent.

Clinical & Logistical Metadata

Parameter	Specification
Test Name	Oncomine Tumor Mutation Burden (TMB) Analysis
Price (AED)	5,600 AED
Turnaround Time	14 – 21 Business Days
Sample Type / Matrix	Archived Formalin-Fixed Paraffin-Embedded (FFPE) Tissue Blocks or Unstained Slides
Methodology Used	Next-Generation Sequencing (NGS) – Oncomine Comprehensive Panel v3
ICD-10-CM Code	Z51.1, C80.1
LOINC Code	96359-1
DHA Facility License & Laboratory Address	DHA License: 1143 \| Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE \| Corporate Lab: DNA Labs UAE