Test Price
600 AED✅ Home Collection Available
RUNX1::RUNX1T1 (AML1‑ETO) t(8;21) Qualitative PCR in Dubai, UAE
Executive Summary & Core Metrics
Executive Summary
- Diagnostic Accuracy: 99.9% analytical sensitivity via ISO 9001:2015 accredited real-time PCR methodology.
- Clinical Logistics: Hospital extraction only – sample collection is conducted strictly within an accredited hospital facility; mobile home phlebotomy is disabled for safety.
- Post‑Test Guidance: Complimentary telephonic consultation with a Consultant Medical Genetics to interpret results.
- Insurance Verification: Direct coverage inquiry via WhatsApp at +971545488731.
Test Overview & Methodology
This qualitative PCR test detects the RUNX1::RUNX1T1 fusion transcript resulting from t(8;21)(q22;q22), a hallmark of a favorable‑risk subtype of acute myeloid leukemia (AML). It is essential for initial diagnosis, risk stratification, and monitoring minimal residual disease (MRD) to guide therapy.
Bone marrow aspirate is the gold standard specimen; peripheral blood may be used after confirmation of circulating blasts. Samples must be collected in a hospital setting under sterile conditions and transported at 2–8°C within 2 hours.
| Feature | Our Test (qPCR) | Standard Karyotyping |
|---|---|---|
| Methodology | Real‑Time PCR (qPCR) with confirmatory Whole Genome Sequencing | Conventional cytogenetics (G‑banding) |
| Sensitivity | 1 in 10⁵ cells | 1 in 20–30 cells |
| Turnaround Time | 3–4 working days | 7–14 days |
| Quantitative MRD | Yes – serial logarithmic reduction | No |
| ISO Accreditation | ISO 9001:2015 | Often non‑accredited |
Physician Insight & Safety Protocols
“A positive RUNX1::RUNX1T1 result confirms the favorable‑risk AML subtype, but it must be correlated with full blood counts and bone marrow morphology. This test is highly sensitive for monitoring remission; a negative result, however, cannot rule out residual leukemic clones below the assay’s threshold. I strongly advise integrating this result with clinical evaluation and never altering therapy based solely on a single PCR value.”
— Lina Osama Zaki Quteineh, Consultant Medical Genetics | DHA Registration ID: 9294403
Advisory: Do Not Discontinue Prescribed Medication
⚠️ Anticoagulant, anti‑platelet, or chemotherapeutic regimens must not be altered or paused based solely on this test result. Always consult your treating physician before making any medication changes.
Safety Exclusion Criteria & ER Red Flags
- Exclusion: Active severe infection, pregnancy (not for clearance), uncontrolled coagulopathy, inability to give informed consent.
- ER Red Flags: Sudden high fever, uncontrolled bleeding, new neurological deficits, or >10% blasts on peripheral smear.
- If any of the above are present, seek immediate emergency care before scheduling this test.
Patient FAQ & Clinical Guidance
1. What does a positive RUNX1::RUNX1T1 test result mean?
Key Insight: A positive result confirms t(8;21) AML, a favorable‑risk subtype requiring specific targeted treatment and monitoring.
This fusion gene is present in approximately 5–10% of adult AML cases and predicts a good response to high‑dose cytarabine consolidation. It is also used to define molecular complete remission when the transcript becomes undetectable.
2. How is the test performed and what sample is required?
Key Insight: Bone marrow or blood (hospital collection only) is chilled immediately; RNA is extracted for PCR detection of the fusion transcript.
Bone marrow aspirate is the gold standard; peripheral blood may be used after confirmation of circulating blasts. Samples must be transported at 2–8°C within 2 hours. Hospital extraction is mandatory – no home phlebotomy is available for this test.
3. Is this test used for monitoring after treatment?
Key Insight: Serial monitoring of the fusion transcript post‑treatment detects minimal residual disease and informs personalized care.
Quantitative PCR at 3‑month intervals tracks log reduction. A ≥3‑log reduction from diagnosis is associated with prolonged remission. Persistently positive results may indicate need for donor lymphocyte infusion or second‑line therapy.
UAE Regulatory & Data Privacy Adherence
Compliance Framework
- Federal Decree‑Law No. 45 of 2021 on Personal Data Protection (PDPL) – all patient data handled under strict consent and encryption.
- Federal Law No. 2 of 2019 Concerning the Use of Information and Communication Technology in Health Fields – secure digital health information exchange.
- Federal Decree‑Law No. 4 of 2016 on Medical Liability – patient safety and clinical consent protocols.
- DHA Facility License No. 1143 – fully licensed for diagnostic molecular biology testing.
- ISO 9001:2015 Certified – Cert: INT/EGQ/2509DA/3139.
Clinical & Logistical Metadata
| Test Name | RUNX1::RUNX1T1 (AML1‑ETO) t(8;21) Qualitative PCR |
| Price (AED) | 600 |
| Turnaround Time | 3–4 working days |
| Sample Type / Matrix | Bone marrow aspirate or peripheral blood (hospital extraction only) |
| Methodology Used | Qualitative Real‑Time PCR (qPCR) with confirmatory Whole Genome Sequencing |
| ICD‑10‑CM Code | C92.0 (Acute myeloblastic leukemia with t(8;21); RUNX1-RUNX1T1) |
| LOINC Code | 11156‑5 (RUNX1/RUNX1T1 fusion transcript [Identifier] in Blood or Bone marrow by PCR) |
| 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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