AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test
Short Name: AML-ETO MRD Monitor
Also known as: AML1-ETO MRD Test, RUNX1-RUNX1T1 Quantitative PCR Test, t(8;21) MRD Monitor, AML-ETO Fusion Gene Quantitative Test, Minimal Residual Disease Monitor for AML t(8;21)
AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test test available at DNA Labs India for ₹7,500. Uses Real-Time Quantitative PCR (RQ-PCR) on 5 mL (3 mL min.) whole blood / Bone marrow in 1 Lavender Top (EDTA) tube samples. Results in Sample acceptance: Monday and Thursday by 11:00 AM. Reports available: Wednesday and Saturday. Reports are delivered via Online Portal, Email, and WhatsApp.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr SULOCHANA HEMCHANDRA HOLLA
Consultant Medical Geneticist · Reg: 8532
Last reviewed: September 7, 2026
Overview
The primary purpose of the AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test is to detect and quantify the RUNX1-RUNX1T1 fusion transcript in patients diagnosed with AML carrying the t(8;21) translocation. By measuring the level of this molecular marker with high sensitivity using Real-Time Quantitative PCR, the test enables clinicians to assess treatment response at a molecular level, detect minimal residual disease before clinical relapse occurs, guide decisions regarding treatment modification or intensification, and monitor patients during long-term follow-up after completion of therapy. This test serves as a critical tool for personalized treatment planning and improved patient outcomes.
- Test Code
- 112
- CPT Code
- 81206
- ICD Code
- C92.0
- Price
- ₹7,500
- Sample Type
- 5 mL (3 mL min.) whole blood / Bone marrow in 1 Lavender Top (EDTA) tube
- Result Time
- Sample acceptance: Monday and Thursday by 11:00 AM. Reports available: Wednesday and Saturday. Reports are delivered via Online Portal, Email, and WhatsApp.
- Fasting Required
- No
- Method
- Real-Time Quantitative PCR (RQ-PCR)
Sample Collection
A duly filled MRD Requisition form (Form 22) with historical baseline data including the initial diagnostic fusion transcript level is mandatory before sample collection. The referring physician should provide complete clinical history, treatment details, and the date of the most recent therapy cycle. No fasting is required. Patients should inform the phlebotomist of any recent blood transfusions. If a bone marrow aspirate is being collected, standard bone marrow biopsy preparation protocols should be followed.
Method: Venipuncture / Bone Marrow Aspiration
Laboratory Analysis
For peripheral blood: 5 mL (minimum 3 mL) of venous blood is collected by venipuncture into a Lavender Top (EDTA) tube using standard aseptic technique. For bone marrow: the sample is obtained via bone marrow aspiration from the posterior iliac crest by the treating physician. The sample must be immediately transferred to an EDTA tube and gently mixed to prevent clotting.
Report Delivery
The sample must be shipped refrigerated (2–8°C). Do NOT freeze the sample. The specimen should reach the laboratory within 24 hours of collection for optimal RNA integrity. Label the sample correctly with patient details and ensure the MRD Requisition form (Form 22) accompanies the sample.
Timeline: Sample acceptance: Monday and Thursday by 11:00 AM. Reports available: Wednesday and Saturday. Reports are delivered via Online Portal, Email, and WhatsApp.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test is to detect and quantify the RUNX1-RUNX1T1 fusion transcript in patients diagnosed with AML carrying the t(8;21) translocation. By measuring the level of this molecular marker with high sensitivity using Real-Time Quantitative PCR, the test enables clinicians to assess treatment response at a molecular level, detect minimal residual disease before clinical relapse occurs, guide decisions regarding treatment modification or intensification, and monitor patients during long-term follow-up after completion of therapy. This test serves as a critical tool for personalized treatment planning and improved patient outcomes.
How to Prepare
- Collect 5 mL (minimum 3 mL) whole blood or bone marrow in a Lavender Top (EDTA) tube
- Gently invert the tube 8–10 times immediately after collection to mix with anticoagulant
- Ship the sample refrigerated (2–8°C) — do NOT freeze
- Ensure the sample reaches the laboratory within 24 hours of collection
- Duly filled MRD Requisition form (Form 22) with historical baseline data is mandatory
- Include date of last treatment, type of treatment received, and prior MRD results on the requisition form
- Sample collection days: Monday and Thursday, sample must arrive by 11:00 AM
Doctor's Notes
Reviewed by Dr SULOCHANA HEMCHANDRA HOLLA — MBBS, MD (Medical Genetics) · Reg. No. 8532
"Quantitative MRD monitoring for the RUNX1-RUNX1T1 fusion transcript is a critical component of risk-adapted therapy in AML patients carrying the t(8;21) translocation. Serial monitoring allows clinicians to detect molecular relapse before hematologic relapse, enabling timely therapeutic intervention. I recommend periodic MRD assessment using Real-Time PCR at defined treatment milestones such as post-induction, post-consolidation, and during follow-up. A rising MRD trend warrants immediate clinical reassessment and possible treatment modification."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample received without a duly filled MRD Requisition form (Form 22)
- Clotted or hemolyzed sample
- Sample received frozen
- Sample volume less than 3 mL
- Sample received after 4 days of collection
- Incorrect sample container (non-EDTA tube)
- Missing or illegible patient identification on the sample
Understanding Your Results
MRD Not Detected / Negative
Favorable prognosis; associated with sustained complete remission.
MRD Detected – Low Level
May indicate residual disease; requires close surveillance.
MRD Detected – Rising Trend
High risk of clinical relapse; urgent clinical reassessment and possible treatment modification recommended.
MRD Detected – High Level
Indicates hematologic or molecular relapse; immediate clinical intervention required.
Invalid / Inconclusive
No clinical interpretation can be made; repeat testing required.
Consult your hematologist or oncologist if your MRD result shows detectable levels of the RUNX1-RUNX1T1 fusion transcript, especially if there is a rising trend compared to previous results. Additionally, seek medical attention if you experience any symptoms suggestive of disease recurrence such as unexplained fatigue, recurrent infections, fever, easy bruising or bleeding, bone pain, or unexplained weight loss. Even if your MRD result is negative, regular follow-up appointments with your treating physician are essential for ongoing disease surveillance.
Limitations
- ⚠This test is specific for the RUNX1-RUNX1T1 fusion transcript and does not detect other AML-associated molecular abnormalities
- ⚠Results should be interpreted in conjunction with clinical findings, morphological evaluation, and other laboratory parameters
- ⚠The sensitivity of the assay depends on the quality and quantity of RNA extracted from the sample
- ⚠A negative result does not completely exclude the presence of residual leukemic cells below the assay's detection limit
- ⚠This test is not intended for initial diagnosis of AML; it is designed for monitoring known t(8;21)-positive AML patients
- ⚠Performance may vary slightly between different laboratories due to assay calibration differences; serial monitoring should ideally be performed at the same laboratory
Risks & Considerations
- ●For blood collection: Minimal risk — slight bruising or discomfort at the venipuncture site
- ●For bone marrow aspiration: Mild pain at the collection site, minor bleeding, and very rare risk of infection at the aspiration site
- ●No known risks associated with the Real-Time PCR laboratory procedure itself
Interfering Factors
- ●Degraded or insufficient RNA quality in the sample may lead to false-negative results
- ●Hemolyzed blood samples may affect RNA extraction efficiency
- ●Improper sample storage or delayed processing can compromise RNA integrity
- ●Concurrent infections or inflammatory conditions may affect cell populations but do not directly interfere with the PCR assay
- ●Prior blood transfusions within 24–48 hours may dilute leukemic cell population in peripheral blood samples
Compare With Similar Tests
| Test | AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test | AML NPM1 MRD Monitor Test | AML CBFB-MYH11 MRD Monitor Test | BCR-ABL1 Quantitative PCR (for CML/ALL) | Flow Cytometry-Based MRD Panel |
|---|---|---|---|---|---|
| Comparison | AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test | NPM1 MRD monitoring detects NPM1 gene mutations common in AML, while the AML-ETO test specifically detects the t(8;21) RUNX1-RUNX1T1 fusion. Both use Real-Time PCR but target different molecular markers. They are mutually exclusive based on the patient's specific genetic abnormality. | CBFB-MYH11 is associated with inv(16)/t(16;16) AML, whereas AML-ETO is associated with t(8;21). Both are core-binding factor leukemias but involve different fusion genes and require separate MRD assays. | BCR-ABL1 monitoring is used for Chronic Myeloid Leukemia and Philadelphia-positive ALL, while AML-ETO MRD is specific for t(8;21) AML. Both are quantitative fusion gene assays but serve different disease contexts. | Flow cytometry MRD detection is applicable across AML subtypes and does not require a specific genetic abnormality. However, Real-Time PCR for AML-ETO offers higher sensitivity (up to 10^-5) compared to flow cytometry (typically 10^-3 to 10^-4) for patients with a known t(8;21) translocation. |
Frequently Asked Questions
What is the AML ETO t(8;21) Gene Rearrangement Quantitative MRD Monitor Test?
What is Minimal Residual Disease (MRD)?
Who should get this test done?
What sample is required for this test?
Is fasting required before the test?
What is the cost of this test?
How is the test performed?
What does a positive (MRD detected) result mean?
What does a negative (MRD not detected) result mean?
How often should this MRD test be repeated?
Is home sample collection available for this test?
When will I receive my test report?
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