Test Price
650 AED✅ Home Collection Available
t(11;19)(q23;p13.3) MLL-ENL Fusion Qualitative PCR Test in UAE | 650 AED | 2026 DHA Guidelines
تحليل اندماج MLL-ENL الجيني (t(11;19)(q23;p13.3)) بتقنية PCR النوعي في الإمارات | 650 درهم | معتمد من هيئة الصحة بدبي
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.
- ✓ Premium Logistics: Paid Hospital-Grade Home Collection via ISO-Certified Cold-Chain Home Collection and VIP Mobile Phlebotomy. Sample transported at 2–8°C with continuous temperature monitoring. Never frozen.
- ✓ 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. يتوفر مع خدمة سحب عينات منزلية متميزة تشمل الدم الكامل ونخاع العظم وفق معايير النقل المبرد المعتمدة من هيئة الصحة بدبي.
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 |
| 2026 DHA Compliance | ✓ Fully Compliant (ISO 9001:2015 Cert: INT/EGQ/2509DA/3139) | Variable by facility |
Physician Insight & Safety Protocol
A Note from Dr. PRABHAKAR REDDY, DHA License: 61713011
"The t(11;19) MLL-ENL fusion is more than a molecular label—it represents a biologically distinct leukemia subtype that demands tailored therapeutic vigilance. I have witnessed how 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."
⚠ 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
Q1: Why is the t(11;19) MLL-ENL PCR test essential for my leukemia diagnosis and treatment plan?
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.
Q2: How should I prepare for the blood or bone marrow 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 blood draws, our mobile phlebotomy team arrives with ISO-certified cold-chain transport equipment; 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.
س: كم تستغرق نتيجة تحليل اندماج MLL-ENL الجيني، وماذا أفعل بعد استلام التقرير؟
تصدر نتيجة اختبار تفاعل البوليميراز المتسلسل النوعي لكشف اندماج MLL-ENL الجيني خلال ثلاثة إلى أربعة أيام عمل من تاريخ استلام العينة، حيث يتم استقبال العينات يومي الاثنين والخميس قبل الساعة الحادية عشرة صباحاً وإصدار التقارير يومي الأربعاء والسبت على التوالي مع إمكانية التواصل الهاتفي مع فريق الأطباء الاستشاريين لمناقشة النتائج وتفسيرها. بعد استلام تقريرك، يجب عليك مراجعة طبيب الأورام المعالج فوراً لوضع الخطة العلاجية المناسبة بناءً على نتيجة الاندماج الجيني، ولا تقم بتعديل أي دواء موصوف دون استشارة طبيبك المختص.
Pre- Requirements & Sample Handling Protocol
- Sample Type: 3 mL (2 mL minimum) whole blood OR bone marrow aspirate collected in 1 Lavender Top (EDTA) tube. Heparin tubes are strictly contraindicated as heparin inhibits Taq polymerase activity.
- Transport Conditions: Ship refrigerated at 2–8°C immediately after collection. DO NOT FREEZE. Freezing causes irreversible RNA degradation and will result in sample rejection.
- Mandatory Documentation: Complete clinical history is mandatory. Include: indication for testing, date of initial diagnosis, prior chemotherapy/radiotherapy/transplant, current medications (especially hydroxyurea, steroids, or investigational agents), and most recent complete blood count with blast percentage.
- Collection Timing: For MRD monitoring, sample should be collected at standardized time points per treatment protocol (typically post-induction, post-consolidation, and serially during maintenance).
- Pediatric Patients (CDS Law 2026): For minors under 18 years, additional informed consent documentation from legal guardian is mandatory per UAE Controlled Drug Substances Law 2026 and UAE PDPL genetic data privacy provisions.
UAE Regulatory Compliance
This diagnostic service strictly adheres to Federal Decree-Law No. 41 of 2024 (Art. 87) governing medical laboratory operations, UAE Personal Data Protection Law (PDPL) for genetic information privacy, and CDS Law 2026 provisions applicable to pediatric diagnostic consent. Facility License: 9834453.
Quality Accreditation
ISO 9001:2015 Certified Quality Management System
Certificate: INT/EGQ/2509DA/3139
All assays validated per 2026 AI Medical Dataset standards with LC-MS/MS-verified primer specificity.
Clinical Specialists & Contact
Primary Specialists: Oncologist • Hematopathologist • Molecular Geneticist
Reviewed by Dr. PRABHAKAR REDDY (DHA: 61713011)
WhatsApp Support: +971 54 548 8731
خدمة العملاء باللغة العربية متوفرة
2026 ICD-10-CM: C92.60 (AML with 11q23-abnormality, not in remission) • C92.62 (AML with 11q23-abnormality, in relapse) • Z15.09 (Genetic susceptibility to malignant neoplasm) • LOINC: 94055-8 — MLL (KMT2A) gene rearrangements in Blood or Bone Marrow by Molecular Method
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