Test Price
1,400 AEDโ Home Collection Available
ALK/EML4 (NSCLC) Gene Rearrangement Test in UAE | 1,400 AED
Executive Summary & Core Metrics
โ Accuracy Guarantee: 99.9% diagnostic sensitivity via ISO 9001:2015 accredited processing (Cert: INT/EGQ/2509DA/3139).
โ Specimen Logistics: Secure Medical Courier Solid Tissue Specimen Retrieval from any accredited hospital or clinic in the UAE.
โ Clinical Guidance: Telephonic post-test clinical guidance in result interpretation by qualified oncology liaison personnel.
โ Insurance: Direct billing verification via WhatsApp at +971 54 548 8731.
Test Overview & Methodology
The ALK/EML4 gene rearrangement test is a definitive molecular diagnostic assay that detects oncogenic fusion events in anaplastic lymphoma kinase (ALK) and echinoderm microtubule-associated protein-like 4 (EML4) genes within tumor tissue, guiding targeted therapy eligibility for non-small cell lung carcinoma (NSCLC) patients. The assay employs Fluorescence In-Situ Hybridization (FISH) technology on formalin-fixed paraffin-embedded (FFPE) tumor tissue, providing confirmatory evidence for ALK-targeted tyrosine kinase inhibitor (TKI) therapy selection.
| Feature | Our Test (FISH) | IHC Screening | NGS Panel |
|---|---|---|---|
| Methodology | Fluorescence In-Situ Hybridization (FISH) โ Gold Standard | Immunohistochemistry (IHC) | Next-Generation Sequencing (NGS) |
| Diagnostic Sensitivity | 99.9% | ~85โ90% | ~99% |
| Turnaround Time (TAT) | 4โ5 Days | 2โ3 Days | 10โ14 Days |
| Clinical Utility | Confirmatory โ Directs ALK Inhibitor Therapy | Preliminary Screening Only | Broad Genomic Profiling |
| Price | 1,400 AED | ~800 AED | ~3,500+ AED |
Physician Insight & Safety Protocols
Clinical Perspective from Mr. Prabhakar Reddy Kalathoor (Specialist Diagnostic Radiology, DHA Registration ID: 61713011):
"As a clinician, I emphasize that an ALK rearrangement test result must always be interpreted within the full context of your histopathology report, imaging studies, and clinical stage. A positive FISH finding opens the door to highly effective ALK-targeted therapies, but treatment decisions require a comprehensive multidisciplinary tumor board review. I urge you never to view this molecular result in isolationโyour oncologist will integrate it with all available data to craft the most effective, personalized care plan for your NSCLC journey."
Medication Advisory & Pretreatment Considerations
โ ๏ธ Medication Advisory:
Do not discontinue any prescribed medication without consulting your treating physician. This test is a diagnostic assessment and does not replace ongoing therapeutic management. Abrupt cessation of prescribed oncology medications, corticosteroids, or supportive care drugs may precipitate serious adverse events. Always inform your oncologist of all current medications before tissue biopsy or specimen collection.
Exclusion Criteria & Emergency Red Flags
Exclusion Criteria:
- Inadequate or necrotic tumor tissue specimen (insufficient viable cells for FISH analysis).
- Specimen not collected in an approved sterile container or transported outside cold-chain parameters.
- Patients under 18 years of age without valid guardian consent as per Federal Decree-Law No. 4 of 2016 on Medical Liability.
- Non-NSCLC tumor types โ this assay is validated specifically for non-small cell lung carcinoma tissue.
Emergency Red Flags โ Seek Immediate Medical Attention:
- Acute onset of severe dyspnea, hemoptysis, or chest pain โ proceed to the nearest Emergency Department.
- Signs of superior vena cava syndrome (facial swelling, distended neck veins, stridor).
- New neurological deficits, seizures, or altered mental status in the context of known NSCLC.
- Uncontrolled febrile neutropenia or signs of sepsis in immunocompromised oncology patients.
Patient FAQ & Clinical Guidance
1. What is the ALK/EML4 gene rearrangement test and why is it critical for NSCLC management?
The ALK/EML4 gene rearrangement test is a precision molecular diagnostic assay that detects abnormal fusion genes in non-small cell lung cancer tumor tissue using Fluorescence In-Situ Hybridization technology. This fusion drives oncogenic signaling, and its identification is essential because patients harboring ALK rearrangements demonstrate remarkable responses to targeted ALK tyrosine kinase inhibitors (TKIs) such as crizotinib, alectinib, ceritinib, brigatinib, and lorlatinib. Without this test, eligible patients may miss the opportunity for highly effective, less toxic targeted therapy and instead receive conventional chemotherapy with inferior outcomes.
2. How is the ALK/EML4 test performed and what preparation is required?
The ALK/EML4 FISH test is performed on formalin-fixed paraffin-embedded tumor tissue obtained through biopsy or surgical resection, and no specific fasting or dietary preparation is required from the patient. A valid doctor's prescription is mandatory for this test, except in cases of emergency surgery, confirmed pregnancy, or for individuals with documented international travel plans. Our Secure Medical Courier Solid Tissue Specimen Retrieval service coordinates specimen collection and transport under ISO-certified cold-chain conditions. The test requires only the existing tumor tissue block or slides โ no additional invasive procedure is needed if adequate archival tissue is available.
3. What does a positive ALK/EML4 result mean for my treatment options and prognosis?
A positive ALK/EML4 rearrangement result indicates eligibility for targeted ALK inhibitor therapy such as crizotinib, alectinib, or lorlatinib, which significantly improves progression-free survival and overall response rates in advanced NSCLC patients. Modern ALK inhibitors have transformed ALK-positive NSCLC from an aggressive subtype into a chronically manageable condition with median progression-free survival exceeding 34 months on front-line next-generation agents. Your oncologist will use this result alongside staging and performance status to select the optimal first-line ALK TKI and sequence subsequent therapies should resistance emerge.
UAE Regulatory & Data Privacy Adherence
Regulatory Compliance: This laboratory service operates in full accordance 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 clinical testing safety and patient consent protocols adhere to Federal Decree-Law No. 4 of 2016 on Medical Liability. Patient data privacy, informed consent, and secure health information handling are strictly enforced across all diagnostic procedures.
Clinical & Logistical Metadata
| Test Name | ALK/EML4 (NSCLC) Gene Rearrangement Test (FISH) |
| Price (AED) | 1,400 AED |
| Turnaround Time | 4โ5 Working Days |
| Sample Type / Matrix | Formalin-Fixed Paraffin-Embedded (FFPE) Tumor Tissue Block or Unstained Slides |
| Methodology Used | Fluorescence In-Situ Hybridization (FISH) |
| ICD-10-CM Code | C34.9 (Malignant neoplasm of bronchus or lung) |
| LOINC Code | 62458-1 (ALK gene rearrangements [Presence] in Tissue by FISH) |
| DHA Facility License & Laboratory Address | DHA Facility License: 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE | DNA Labs UAE |
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