Test Price
800 AED✅ Home Collection Available
Inv(16)(p13q22) / t(16;16)(p13q22) Gene Rearrangement Qualitative PCR | 800 AED | DNA Labs UAE
Executive Summary & Core Metrics
- ✓Accuracy Guarantee: 99.9% Diagnostic Sensitivity via ISO-Accredited Processing (ISO 9001:2015 Cert: INT/EGQ/2509DA/3139).
- ✓Specimen Collection: Hospital Extraction Only – Sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety.
- ✓Clinical Guidance: Telephonic Post-Test Clinical Guidance in result interpretation.
- ✓Insurance: Direct Billing Verification via WhatsApp +971 54 548 8731
Test Overview & Methodology
This high-precision qualitative real‑time PCR detects the CBFB-MYH11 gene rearrangement resulting from inv(16)(p13q22) or t(16;16)(p13q22), the hallmark genetic lesion in acute myeloid leukemia (AML) with abnormal eosinophils. Detection of this fusion gene is critical for diagnosis, risk stratification, and minimal residual disease monitoring. The test employs real‑time quantitative PCR (qPCR) with optional confirmation through whole genome sequencing when clinically indicated.
| Feature | Our Test (ISO Certified) | Closest Alternative |
|---|---|---|
| Methodology | Real‑Time PCR (qPCR) with optional Whole Genome Sequencing (WGS) confirmation | Standard PCR or FISH (lower sensitivity, no WGS backup) |
| Turnaround Time | Sample Mon/Thu by 11 am → Report Wed/Sat | Often 5‑7 working days |
| Sample Logistics | Hospital extraction with ISO‑certified cold‑chain transport and mandatory Form 20 | Self‑drop or non‑dedicated courier |
Physician Insight & Safety Protocols
“As your consultant in medical genetics, I want to emphasize that this test is a cornerstone of precision oncology. A positive result identifies the exact genetic driver, enabling targeted therapies and minimal residual disease monitoring. However, always interpret the result in the full clinical context—morphology and flow cytometry are equally essential. Do not discontinue prescribed medication without consulting your doctor.”
— Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403
Advisory Notice
Safety Exclusion Criteria & ER Red Flags
- Exclusion: Patients with severe thrombocytopenia (platelets < 20×10⁹/L) due to bleeding risk; pregnancy (relative).
- Minors: Must have legal guardian consent as per Federal Decree-Law No. 4 of 2016 on Medical Liability.
- Red Flags: If you experience high fever with rigors, uncontrolled hemorrhage, sudden breathlessness, or severe pain at the collection site after the procedure, seek emergency care immediately.
Exclusion Criteria
Patients with severe thrombocytopenia or those unable to provide informed consent due to cognitive impairment should be evaluated carefully. For minors, consent from a legal guardian is mandatory under UAE Federal Decree-Law No. 4 of 2016 on Medical Liability. The test is not recommended during pregnancy unless the potential benefit clearly outweighs the procedural risk.
Patient FAQ & Clinical Guidance
1. What is the Inv(16)/t(16;16) gene rearrangement test and why is it important for leukemia patients?
Quick Answer: The qualitative PCR detects CBFB-MYH11 gene rearrangement, essential for diagnosing and monitoring acute myeloid leukemia (AML).
This test identifies a specific chromosomal abnormality found in approximately 5‑12% of AML cases, notably those with eosinophilic differentiation. A positive result confirms the presence of the CBFB-MYH11 fusion, which influences prognosis and eligibility for targeted therapy. Serial monitoring by PCR can detect relapse earlier than morphology alone.
2. How should I prepare for sample collection, and what special requirements apply?
Quick Answer: You must use a lavender-top EDTA tube, keep sample refrigerated, and submit a completed Form 20 for valid testing.
The test requires 3 mL of whole blood or bone marrow aspirate collected in a lavender‑top EDTA tube. The sample must be stored and transported refrigerated (2‑8°C), never frozen, and reach the lab within 24 hours. A duly filled Genomics Clinical Information Requisition Form (Form 20) is mandatory to ensure accurate interpretation. Collection is performed within an accredited hospital facility.
3. What do positive or negative results mean, and how will they affect my treatment?
Quick Answer: A positive result confirms the specific inv(16)/t(16;16) lesion, guiding targeted therapy; a negative excludes it.
A positive result indicates the CBFB-MYH11 fusion gene is present, classifying the leukemia as favorable‑risk and potentially responsive to specific agents like gemtuzumab ozogamicin. It also enables quantitative monitoring of treatment response. A negative result means this particular rearrangement was not detected; however, the leukemia may still harbor other genetic changes. Your oncologist will integrate the result with other diagnostics to tailor your therapy.
UAE Regulatory & Data Privacy Adherence
DNA Labs UAE operates in full compliance with UAE federal data protection and health information governance frameworks. Patient data is processed under 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 genetic information is handled with strict confidentiality, encrypted during transmission and storage, and accessible only to authorized clinical personnel. Our DHA-licensed facility (License No. 1143) adheres to the highest standards of medical data security and patient privacy.
Clinical & Logistical Metadata
| Test Name | Inv(16)(p13q22) / t(16;16)(p13q22) Gene Rearrangement Qualitative PCR |
| Price (AED) | 800 |
| Turnaround Time | Sample Mon/Thu by 11 am → Report Wed/Sat |
| Sample Type / Matrix | Whole Blood or Bone Marrow Aspirate (Hospital Extraction Only) |
| Methodology Used | Real-Time PCR (qPCR) with Optional Whole Genome Sequencing Confirmation |
| ICD-10-CM Code | C92.8 |
| LOINC Code | 33680-6 |
| DHA Facility License & Laboratory Address | DHA License No. 1143 | Premises 105, Floor 1, Building 33, Dubai Healthcare City, Dubai, UAE |
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