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Test Price

1,400 AED

✅ Home Collection Available

Epidermal Growth Factor Receptor (EGFR) Mutation Analysis (Exons 18–21) – Targeted Cancer Therapy Guidance in Dubai

Executive Summary & Core Metrics

  • Clinical Utility: High-sensitivity detection of clinically actionable EGFR mutations (exons 18–21) to guide first-, second-, and third-generation tyrosine kinase inhibitor (TKI) therapy in non-small cell lung cancer (NSCLC).
  • Methodological Accuracy: 99.9% diagnostic sensitivity achieved via gold-standard Sanger sequencing with orthogonal next-generation sequencing (NGS) reflex confirmation.
  • Specimen Logistics Protocol: Hospital Extraction Only – Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety. Secure medical courier retrieval for FFPE tissue blocks or biopsy slides.
  • Post-Test Clinical Guidance: Complimentary telephonic result interpretation and genetic counseling session provided by a DHA-licensed Consultant Medical Geneticist.
  • Insurance & Billing: Direct insurance coverage verification and billing support available via WhatsApp at +971 54 548 8731.

Test Overview & Methodology

The Epidermal Growth Factor Receptor (EGFR) Mutation Analysis is a precision molecular diagnostic assay that precisely identifies single nucleotide variants (SNVs) and insertion/deletion (indel) mutations specifically within exons 18, 19, 20, and 21 of the EGFR gene. Detection of these specific mutations, such as exon 19 deletions and the exon 21 L858R point mutation, is critical for determining eligibility and predicting response to targeted tyrosine kinase inhibitor (TKI) therapies in patients with non-small cell lung cancer (NSCLC) and other solid tumors. Our dual-platform approach combines the established accuracy of Sanger sequencing with the enhanced sensitivity of NGS for complex or low-frequency variant detection.

Feature DNA Labs UAE EGFR Analysis (Sanger + NGS Reflex) Standard Broad NGS Panel
Methodology Gold-standard Sanger Sequencing with mandatory reflex to NGS for confirmation and rare variant detection. NGS panel only (may lack the specific depth required for certain clinically relevant indels in exons 19 & 20).
Turnaround Time 3–4 Working Days 7–10 Working Days
Price (AED) 1,400 1,800 – 2,200
Regulatory Compliance DHA, PDPL (Federal Decree-Law No. 45/2021), Federal Law No. 2/2019, ISO 9001:2015 Variable; often lacks mandated genetic counseling framework.
Post-Test Support Telephonic Clinical Guidance & Insurance Billing Verification Limited or none.

Physician Insight & Safety Protocols

"As a Consultant Medical Geneticist, I affirm that comprehensive EGFR exon 18–21 mutation analysis is the molecular cornerstone for guiding first-line tyrosine kinase inhibitor therapy in advanced NSCLC. However, a positive result must never be interpreted as a standalone diagnosis; it must be seamlessly integrated with the full histopathological subtype, clinical staging, and overall performance status of the patient by a board-certified oncologist. I strongly urge all patients to participate in a dedicated genetic counseling session to fully understand the therapeutic, prognostic, and potential hereditary implications of their molecular profile."

— Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403

⚠️ Medication Therapy Advisory

This test result is an adjunct to clinical decision-making and is not a standalone directive. Do not discontinue, initiate, or alter any prescribed oncologic therapy, including tyrosine kinase inhibitors, based solely on the findings of this assay without the explicit consultation and guidance of your treating physician.

Patient Safety – Exclusion Criteria & Emergency Red Flags

  • Exclusion Criteria:
    • This test is strictly contraindicated for self-diagnosis or direct-to-consumer use without a valid referring physician.
    • A completed and signed physician's prescription is mandatory for processing.
    • Not indicated for minor patients unless accompanied by a legal guardian and informed consent is provided.
    • Patients who are unable to provide informed consent or lack a responsible physician for follow-up are excluded.
  • ER Red Flags (Seek Immediate Medical Attention):
    • Sudden new-onset hemoptysis (coughing up blood) or severe, unrelenting chest pain.
    • Rapid unexplained weight loss or persistent high fever accompanied by acute respiratory distress.
    • Any acute neurological changes such as confusion, seizures, or focal weakness that may indicate disease progression.

For medical emergencies, dial 998 or proceed to the nearest UAE emergency department. For test-related inquiries, contact us via WhatsApp at +971 54 548 8731.

Patient FAQ & Clinical Guidance

1. What specific mutations does the EGFR test detect?

This assay targets clinically actionable mutations within exons 18 through 21 of the EGFR gene. This includes exon 19 deletions, the exon 21 L858R point mutation, exon 20 insertions (including T790M resistance mutation), and other rare SNVs. Identifying the exact mutation enables your oncologist to select the most effective targeted tyrosine kinase inhibitor for your specific cancer profile.

2. How is the tissue sample obtained for this analysis?

The analysis requires a tumor tissue sample, typically obtained via a core needle biopsy or surgical resection performed strictly within an accredited hospital setting. Once extracted, the tissue is formalin-fixed and paraffin-embedded (FFPE). Our team coordinates the Secure Medical Courier Solid Tissue Specimen Retrieval from your hospital to our laboratory. Home phlebotomy services are disabled for this invasive specimen type to ensure patient safety and sample integrity.

3. What is the expected turnaround time for the results?

Our standard turnaround time for EGFR Mutation Analysis is 3 to 4 working days from the moment the FFPE tissue block or slides are received in our laboratory. This advanced timeline is achieved through our streamlined Sanger sequencing process with an optional NGS reflex for complex cases, ensuring you receive a comprehensive molecular report without unnecessary delays.

4. How can I verify my insurance coverage for this test?

Insurance eligibility and direct billing options can be verified conveniently through a single WhatsApp message to +971 54 548 8731. Our billing team will coordinate directly with your UAE-based insurance provider to confirm coverage for molecular oncology testing. A valid physician's prescription is generally required, though exceptions apply for planned surgical procedures or travel under UAE regulations.

UAE Regulatory & Data Privacy Adherence

All laboratory and data processing workflows at DNA Labs UAE are fully compliant with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL), guaranteeing that your genetic and medical information is collected, stored, and processed with the highest standards of confidentiality and security. We adhere strictly to Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields, governing the ethical handling of electronic health records and telemedicine consultations. Our clinical liability framework is anchored in Federal Decree-Law No. 4 of 2016 on Medical Liability, ensuring patient safety and rights are protected throughout the entire diagnostic journey.

Clinical & Logistical Metadata

Test Name Epidermal Growth Factor Receptor (EGFR) Mutation Analysis (Exons 18–21)
Price (AED) 1,400
Turnaround Time 3–4 Working Days
Sample Type / Matrix Formalin-Fixed Paraffin-Embedded (FFPE) Tumor Tissue Block, Biopsy Slides, or Surgical Pathology Cuts
Methodology Used Gold-Standard Sanger Sequencing with Reflex to Next-Generation Sequencing (NGS) for Complex Variant Confirmation
ICD-10-CM Code C34.9 (Malignant neoplasm of bronchus/lung), Z85.1 (Personal history of NSCLC)
LOINC Code 5827-7
DHA Facility License & Laboratory Address License No: 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE | DNA Labs UAE

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