RUNX1-RUNX1T1 (AML1- ETO) t(8;21) Quantitative Test
Short Name: RUNX1-RUNX1T1 Quantitative
Also known as: AML1-ETO Quantitative Test, RUNX1-RUNX1T1 Fusion Gene Quantitative, t(8;21) Quantitative PCR, AML1-ETO t(8;21) Quantitative, Core Binding Factor Alpha Quantitative
RUNX1-RUNX1T1 (AML1- ETO) t(8;21) Quantitative Test test available at DNA Labs India for ₹6,000. Uses Real-Time Quantitative PCR (RQ-PCR) on Bone marrow / Peripheral blood samples. Results in Results are typically available within 3–4 working days from sample receipt at the laboratory.. 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 RUNX1-RUNX1T1 Quantitative Test is performed to detect and measure the level of the RUNX1-RUNX1T1 fusion gene transcript in patients with Acute Myeloid Leukemia. This test is used at diagnosis to confirm the presence of the t(8;21) translocation, during treatment to monitor minimal residual disease (MRD), and during follow-up surveillance to detect early molecular relapse before clinical or haematological relapse becomes apparent. Quantitative monitoring enables treating oncologists to make informed decisions regarding treatment intensification, continuation of therapy, or consideration of allogeneic stem cell transplantation.
- Test Code
- 3201
- CPT Code
- 81206
- ICD Code
- C92.0
- Price
- ₹6,000
- Sample Type
- Bone marrow / Peripheral blood
- Result Time
- Results are typically available within 3–4 working days from sample receipt at the laboratory.
- Fasting Required
- No
- Method
- Real-Time Quantitative PCR (RQ-PCR)
Sample Collection
No special preparation such as fasting is required. Ensure a valid doctor's prescription is available. Inform the phlebotomist or physician about any anticoagulant therapy or recent blood transfusions. For bone marrow aspiration, the procedure will be explained by the treating physician and appropriate consent will be obtained.
Method: Venipuncture / Bone marrow aspiration
Laboratory Analysis
For peripheral blood: A standard venipuncture will be performed and approximately 2 ml of blood will be collected into an EDTA vacutainer. For bone marrow: The sample will be collected by the treating physician via bone marrow aspiration, typically from the posterior iliac crest, under local anaesthesia. The sample is then transferred to an EDTA vacutainer.
Report Delivery
The sample must be transported to the laboratory immediately at room temperature or with a cool pack. Avoid freezing the sample. Apply pressure to the venipuncture or aspiration site for adequate haemostasis. Mild soreness at the collection site is normal and typically resolves within a day.
Timeline: Results are typically available within 3–4 working days from sample receipt at the laboratory.
Patient Instructions
About This Test
Who Should Get This Test
The RUNX1-RUNX1T1 Quantitative Test is performed to detect and measure the level of the RUNX1-RUNX1T1 fusion gene transcript in patients with Acute Myeloid Leukemia. This test is used at diagnosis to confirm the presence of the t(8;21) translocation, during treatment to monitor minimal residual disease (MRD), and during follow-up surveillance to detect early molecular relapse before clinical or haematological relapse becomes apparent. Quantitative monitoring enables treating oncologists to make informed decisions regarding treatment intensification, continuation of therapy, or consideration of allogeneic stem cell transplantation.
How to Prepare
- Collect 2 ml of bone marrow aspirate or peripheral blood in an EDTA vacutainer
- Transport the sample immediately to the laboratory at 2–8°C with a cool pack
- Do not freeze the sample
- Label the sample clearly with patient details, date, and time of collection
- Ensure the sample reaches the laboratory within 24 hours of collection
- Avoid haemolysed or clotted samples
Doctor's Notes
Reviewed by Dr SULOCHANA HEMCHANDRA HOLLA — MBBS, MD (Medical Genetics) · Reg. No. 8532
"The RUNX1-RUNX1T1 fusion gene resulting from t(8;21) translocation is one of the most clinically significant molecular markers in Acute Myeloid Leukemia. Patients harboring this translocation are classified under the WHO category of AML with recurrent genetic abnormalities and generally carry a favorable prognosis when treated with standard chemotherapy regimens including cytarabine-based consolidation. Quantitative monitoring of this fusion transcript using RQ-PCR is essential for minimal residual disease (MRD) assessment during and after treatment. A rising transcript level during follow-up may indicate impending molecular relapse, allowing clinicians to intervene early. I recommend this test at diagnosis, post-induction, post-consolidation, and during long-term surveillance for all patients with t(8;21)-positive AML. Early detection of molecular relapse through serial quantitative monitoring can significantly improve patient outcomes by enabling timely therapeutic decisions."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Clotted or haemolysed samples
- Samples received without proper labelling or identification
- Samples collected in incorrect anticoagulant (non-EDTA)
- Samples received beyond the acceptable stability window
- Insufficient sample volume
- Samples without a valid doctor's prescription (where applicable)
Understanding Your Results
Not Detected / Negative
No RUNX1-RUNX1T1 fusion transcript was detected. In a known t(8;21)-positive AML patient on follow-up, this suggests molecular remission. In a newly suspected case, this does not exclude AML as other subtypes may be present.
Detected / Positive (at diagnosis)
The RUNX1-RUNX1T1 fusion gene is present, confirming t(8;21)-positive AML. This is generally associated with a favourable prognosis. The quantitative baseline value is recorded for future MRD monitoring.
Detected / Positive (low level during follow-up)
A low but detectable level of the fusion transcript during follow-up may indicate minimal residual disease. Close monitoring with repeat testing is recommended. Clinical correlation is essential.
Detected / Positive (rising level during follow-up)
A rising trend in fusion transcript levels during surveillance may indicate impending molecular relapse. Urgent clinical evaluation and consideration of therapeutic intervention is recommended. Consult your treating oncologist immediately.
Consult your doctor or treating oncologist if you have been diagnosed with AML and your test results show detectable or rising levels of the RUNX1-RUNX1T1 fusion transcript. Additionally, consult a physician if you experience symptoms such as persistent fever, unexplained fatigue, easy bruising or bleeding, frequent infections, bone pain, or unexplained weight loss, as these may indicate a haematological disorder requiring evaluation.
Limitations
- ⚠This test detects only the RUNX1-RUNX1T1 fusion transcript and does not identify other AML-associated genetic abnormalities
- ⚠A negative result does not exclude the diagnosis of AML, as other molecular subtypes exist
- ⚠Quantitative results should be interpreted alongside clinical findings, morphology, flow cytometry, and conventional cytogenetics
- ⚠Sensitivity may vary depending on sample quality and laboratory methodology
- ⚠This test is not a substitute for conventional cytogenetic analysis or FISH studies at initial diagnosis
- ⚠Peripheral blood samples may have lower sensitivity compared to bone marrow samples for MRD detection
Risks & Considerations
- ●For peripheral blood collection: Minor bruising, slight pain, or infection at the puncture site (rare)
- ●For bone marrow aspiration: Localised pain at the aspiration site, minor bleeding, bruising, or infection (uncommon)
- ●No significant long-term risks are associated with either sample collection method
Interfering Factors
- ●Degraded RNA due to delayed sample processing or improper storage conditions
- ●Haemolysed blood samples may affect RNA quality and yield
- ●Sample contamination during collection or transport
- ●Insufficient sample volume or low cellularity in bone marrow aspirate
- ●Concurrent use of certain chemotherapeutic agents may affect transcript levels temporarily
Compare With Similar Tests
| Test | RUNX1-RUNX1T1 (AML1- ETO) t(8;21) Quantitative | PML-RARA (t(15;17)) Quantitative | CBFB-MYH11 (inv(16)/t(16;16)) Quantitative | FLT3 Mutation Analysis (ITD and TKD) | NPM1 Mutation Analysis | BCR-ABL1 (Philadelphia Chromosome) Quantitative |
|---|---|---|---|---|---|---|
| Comparison | RUNX1-RUNX1T1 (AML1- ETO) t(8;21) Quantitative | Detects the PML-RARA fusion gene associated with Acute Promyelocytic Leukemia (APL), a distinct AML subtype. Unlike RUNX1-RUNX1T1, PML-RARA-positive APL is treated with all-trans retinoic acid (ATRA) and arsenic trioxide. Both tests are used for MRD monitoring. | Detects the CBFB-MYH11 fusion gene, another core binding factor (CBF) AML marker alongside RUNX1-RUNX1T1. Both are associated with a favourable prognosis. Testing for both markers is recommended in suspected CBF-AML cases. | FLT3 mutations are among the most common genetic alterations in AML and carry prognostic significance independent of the RUNX1-RUNX1T1 status. FLT3-ITD is generally associated with an adverse prognosis, while FLT3-TKD has variable prognostic impact. FLT3 inhibitors are available for targeted therapy. | NPM1 mutations are frequently found in AML and, when occurring without FLT3-ITD, are associated with a favourable prognosis. NPM1 mutation status is assessed alongside RUNX1-RUNX1T1 for comprehensive risk stratification in AML. | BCR-ABL1 detects the Philadelphia chromosome translocation t(9;22), primarily associated with Chronic Myeloid Leukemia (CML) and a subset of ALL. Unlike RUNX1-RUNX1T1, BCR-ABL1-positive leukaemias are treated with tyrosine kinase inhibitors. Both tests use RQ-PCR for quantitative monitoring. |
Frequently Asked Questions
What is the RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Quantitative Test?
What is the cost of the RUNX1-RUNX1T1 Quantitative Test in India?
What sample is required for this test?
Is fasting required before the RUNX1-RUNX1T1 Quantitative Test?
How long does it take to get the results?
What does a positive RUNX1-RUNX1T1 result mean?
What does a negative RUNX1-RUNX1T1 result mean?
Who should get the RUNX1-RUNX1T1 Quantitative Test?
Is the RUNX1-RUNX1T1 Quantitative Test available for home sample collection?
What is the difference between the RUNX1-RUNX1T1 Qualitative and Quantitative tests?
Do I need a doctor's prescription for this test?
What is the significance of the t(8;21) translocation in AML?
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