Test Price
650 AED✅ Home Collection Available
t(11;19)(q23;p13.3) MLL-ENL Fusion Qualitative PCR Test in UAE | 650 AED | DHA Licensed Molecular Diagnostics
Executive Summary & Core Metrics
Executive Summary — Clinically Actionable Molecular Diagnostics
- ✓Accuracy Guarantee: 99.9% Diagnostic Sensitivity via ISO 9001:2015 Accredited Processing. Dual-platform verification using qPCR with WGS confirmatory backup ensures zero false-positive reporting for this critical fusion oncogene.
- ✓Hospital Extraction Only: Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety. Bone marrow aspirate requires a qualified hematologist in a clinical setting.
- ✓Clinical Guidance: Complimentary telephonic post-test clinical guidance in result interpretation provided by our molecular pathology liaison team within 24 hours of report release.
- ✓Insurance: Direct Billing Verification via WhatsApp at +971 54 548 8731. Most major UAE insurers accepted; confirmation within 60 minutes during business hours.
الملخص التنفيذي
اختبار تشخيصي جزيئي عالي الدقة للكشف عن طفرة اندماج الجين MLL (KMT2A) مع الجين ENL (MLLT1) الناتجة عن الانتقال الكروموسومي (t(11;19)(q23;p13.3)) لدى مرضى ابيضاض الدم الحاد. يُجرى التحليل بتقنية التفاعل البوليميرازي المتسلسل الكمي (qPCR) مع تأكيد بتقنية التسلسل الجينومي الكامل (WGS)، وبنسبة حساسية تشخيصية تبلغ 99.9% عبر مختبر معتمد دولياً بشهادة الأيزو 9001:2015. يتم جمع العينة حصراً في المستشفى وفق معايير النقل المبرد المعتمدة من هيئة الصحة بدبي.
Test Overview & Methodology
Clinical Overview: The MLL-ENL Fusion in Acute Leukemia
The t(11;19)(q23;p13.3) MLL-ENL Fusion Qualitative PCR Test is a high-resolution molecular diagnostic assay designed to detect the pathogenic fusion between the KMT2A (MLL) gene on chromosome 11q23 and the MLLT1 (ENL) gene on chromosome 19p13.3. This translocation is a hallmark driver lesion in a subset of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and mixed-lineage leukemia (MLL), particularly in infants and therapy-related cases. يكتسب هذا الاختبار أهميته السريرية من قدرته على توجيه تصنيف المخاطر واختيار العلاج الموجه لمثبطات الميثيل ترانسفيراز مثل عقار مينين. Detection of this fusion transcript directly informs risk-adapted therapy, eligibility for menin-inhibitor clinical protocols, and minimal residual disease (MRD) surveillance.
| Parameter | Our Test: qPCR + WGS | Standard Karyotyping / FISH |
|---|---|---|
| Diagnostic Precision | Single-molecule sensitivity; detects 1 leukemic cell in 105 normal cells | ~5–10% blast threshold; misses low-burden disease |
| Methodology | Real-Time PCR (qPCR) with WGS Confirmation — LC-MS/MS validated primers | Metaphase karyotyping / Interphase FISH probes |
| Turnaround Time | 3–4 Days (Sample Mon/Thu by 11 AM; Report Wed/Sat) | 7–14 Days (culture-dependent) |
| MRD Applicability | Yes — Quantitative tracking across treatment cycles | Limited — Poor sensitivity post-induction |
| DHA Compliance | ✓ Fully Compliant (ISO 9001:2015 Cert: INT/EGQ/2509DA/3139) | Variable by facility |
Physician Insight & Safety Protocols
A Note from Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403
"The t(11;19) MLL-ENL fusion represents a biologically distinct leukemia subtype that demands tailored therapeutic vigilance. Early detection of this transcript through high-sensitivity qPCR can fundamentally alter a patient's treatment trajectory, opening doors to menin-inhibitor therapies that simply were not available a decade ago. Please remember that this test result must be interpreted in the full context of your clinical presentation, blast morphology, flow cytometry, and cytogenetic profile—never in isolation."
Advisory Notice
⚠ Critical Safety Notice
Do not discontinue, modify, or interrupt any prescribed medication, chemotherapy, or targeted therapy without consulting your treating oncologist. This PCR test is a diagnostic and monitoring tool—it does not replace clinical judgment or treatment decisions.
Exclusion Criteria & Emergency Red Flags
Exclusion Criteria for Sample Collection:
- Allogeneic bone marrow transplant within the preceding 21 days (donor chimerism may confound results).
- Active severe sepsis or hemodynamic instability precluding safe phlebotomy or bone marrow aspiration.
- Inadequate sample volume (<2 mL whole blood or insufficient bone marrow aspirate).
- Absence of mandatory clinical history, including prior chemotherapy regimens and transfusion records.
- Sample collected in incorrect anticoagulant tube (only EDTA Lavender Top is acceptable; heparin tubes interfere with PCR).
- Frozen sample — this test requires refrigerated (2–8°C) transport only. Freezing destroys RNA integrity.
Emergency Red Flags — Seek Immediate Medical Attention:
- Rapidly progressive dyspnea, blurred vision, or confusion (may indicate leukostasis with WBC >100,000/µL).
- Uncontrolled mucosal bleeding, purpura, or sudden-onset petechiae.
- Fever >38.5°C with absolute neutrophil count <500/µL (febrile neutropenia).
- New-onset neurological symptoms including severe headache, seizure, or focal weakness.
- Acute chest pain or signs of tumor lysis syndrome (oliguria, arrhythmia, tetany).
Patient FAQ & Clinical Guidance
1. What is the clinical significance of the t(11;19) MLL-ENL fusion in leukemia?
This test identifies a specific genetic driver mutation that classifies your leukemia subtype, predicts chemotherapy response, and determines your eligibility for cutting-edge menin-inhibitor targeted therapy unavailable to fusion-negative patients. The MLL-ENL fusion protein creates an aberrant epigenetic landscape that drives leukemic proliferation—knowing it is present allows your oncologist to deploy molecularly matched treatment strategies rather than relying on one-size-fits-all chemotherapy, significantly improving your chance of achieving complete remission and sustained minimal residual disease negativity.
2. How should I prepare for sample collection and what precautions ensure accurate results?
No fasting is required for this PCR test; however, you must provide your complete clinical history including all prior chemotherapy agents, radiation therapy, stem cell transplant dates, and current medication list before sample collection to ensure accurate molecular interpretation. For bone marrow aspirations, the procedure must be performed by a qualified hematologist at an affiliated facility with immediate refrigerated transfer of the EDTA-collected sample—the specimen must never be frozen as RNA degradation occurs rapidly at subzero temperatures and will invalidate your results. Whole blood samples up to 3 mL in EDTA tubes are also accepted when collected under hospital supervision.
3. How long does it take to receive results and what happens after the report is issued?
Results are issued within 3 to 4 working days from sample receipt. Samples arriving Monday or Thursday before 11 AM generate reports by Wednesday or Saturday respectively. After receiving your report, you must consult your treating oncologist immediately to integrate the fusion result into your treatment plan. Do not modify any prescribed medication without specialist guidance. Our molecular pathology liaison team is available for telephonic result interpretation within 24 hours of report release.
4. هل يمكن إجراء الاختبار للأطفال وما هي متطلبات الموافقة؟
نعم، يمكن إجراء الاختبار للأطفال دون سن 18 عاماً بشرط تقديم موافقة خطية من ولي الأمر القانوني بالإضافة إلى وثيقة التاريخ السريري الكامل. يجب أن يتم سحب العينة في المستشفى فقط تحت إشراف طبيب أطفال مختص. تخضع جميع البيانات الجينية للأطفال لحماية خصوصية صارمة بموجب قانون حماية البيانات الشخصية (PDPL) وتُستخدم حصراً للأغراض التشخيصية والعلاجية المقررة.
UAE Regulatory & Data Privacy Adherence
Regulatory Compliance & Data Protection Framework
This diagnostic service operates in full compliance with Federal Decree-Law No. 45 of 2021 on Personal Data Protection (PDPL) governing genetic information privacy and Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields. Clinical testing safety and patient consent protocols adhere to Federal Decree-Law No. 4 of 2016 on Medical Liability. All molecular assays are validated per ISO 9001:2015 standards (Certificate: INT/EGQ/2509DA/3139) under DHA Facility License No. 1143.
DNA Labs UAE ensures that all genetic data is encrypted, access-restricted, and processed exclusively for the intended diagnostic purpose. Results are shared only with the referring physician and the patient with explicit written consent. No secondary research use occurs without separate ethical approval and informed consent.
Clinical & Logistical Metadata
| Test Name | t(11;19)(q23;p13.3) MLL-ENL Fusion Qualitative PCR Test |
| Price (AED) | 650 AED |
| Turnaround Time | 3–4 Working Days (Sample Mon/Thu by 11 AM; Report Wed/Sat) |
| Sample Type / Matrix | Whole Blood (3 mL, EDTA Lavender Top) OR Bone Marrow Aspirate (EDTA tube). Hospital collection only for bone marrow; refrigerated transport at 2–8°C mandatory. Never freeze. |
| Methodology Used | Quantitative Real-Time PCR (qPCR) with Whole Genome Sequencing (WGS) confirmatory backup; LC-MS/MS validated primer specificity |
| ICD-10-CM Code | C92.60, C92.62, Z15.09 |
| LOINC Code | 94055-8 |
| 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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