t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test
Short Name: MLL-ENL PCR Qualitative Test
Also known as: MLL-ENL Fusion Gene Test, t(11;19) Translocation PCR Test, MLL Gene Rearrangement Test, Mixed Lineage Leukemia-ENL Fusion Test
t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test test available at DNA Labs India for ₹5,000. Uses Real Time PCR (Polymerase Chain Reaction) on Whole blood / Bone marrow samples. Results in Sample collection: Monday or Thursday by 11:00 AM. Report availability: Wednesday or Saturday. Results are delivered via online portal, email, and WhatsApp.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Pasupathy Arumugam
Consultant Pathologist · Reg: 21521
Last reviewed: September 7, 2026
Overview
The primary purpose of the t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test is to detect the presence of the MLL-ENL fusion gene, which is a hallmark genetic abnormality associated with certain subtypes of leukemia. This test aids in confirming the molecular diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) carrying the MLL-ENL rearrangement. Detection of this fusion gene is important for risk stratification, prognosis assessment, treatment selection, and monitoring minimal residual disease. The MLL-ENL rearrangement is recognized as a clinically significant biomarker that influences therapeutic decisions, including the potential need for intensive chemotherapy regimens or consideration of allogeneic hematopoietic stem cell transplantation.
- Test Code
- 1428
- CPT Code
- 81207
- ICD Code
- C92.0
- Price
- ₹5,000
- Sample Type
- Whole blood / Bone marrow
- Result Time
- Sample collection: Monday or Thursday by 11:00 AM. Report availability: Wednesday or Saturday. Results are delivered via online portal, email, and WhatsApp.
- Fasting Required
- No
- Method
- Real Time PCR (Polymerase Chain Reaction)
Sample Collection
Clinical history is mandatory. Inform the healthcare provider about any recent blood transfusions, medications, or ongoing treatments. No fasting is required for this test.
Method: Venipuncture / Bone marrow aspiration
Laboratory Analysis
A trained healthcare professional will collect approximately 3 mL of whole blood via venipuncture into a Lavender Top (EDTA) tube. If a bone marrow sample is required, the procedure will be performed by a specialist.
Report Delivery
Apply gentle pressure to the puncture site with a cotton ball or gauze. Mild bruising may occur and typically resolves within a few days. The sample will be shipped refrigerated to the laboratory.
Timeline: Sample collection: Monday or Thursday by 11:00 AM. Report availability: Wednesday or Saturday. Results are delivered via online portal, email, and WhatsApp.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test is to detect the presence of the MLL-ENL fusion gene, which is a hallmark genetic abnormality associated with certain subtypes of leukemia. This test aids in confirming the molecular diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) carrying the MLL-ENL rearrangement. Detection of this fusion gene is important for risk stratification, prognosis assessment, treatment selection, and monitoring minimal residual disease. The MLL-ENL rearrangement is recognized as a clinically significant biomarker that influences therapeutic decisions, including the potential need for intensive chemotherapy regimens or consideration of allogeneic hematopoietic stem cell transplantation.
How to Prepare
- Sample must be collected in a Lavender Top (EDTA) tube
- Minimum 2 mL of whole blood or bone marrow is required
- Ship the sample refrigerated. DO NOT FREEZE
- Clinical history must be provided along with the sample
- Label the sample correctly with patient details and date of collection
- Submit the sample on Monday or Thursday by 11:00 AM for timely report delivery
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"The MLL-ENL fusion gene, resulting from the t(11;19)(q23;p13.3) translocation, is observed with equal frequency in both acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Early detection through qualitative PCR is critical for risk stratification and guiding targeted treatment strategies. Patients diagnosed with MLL rearrangements often have distinct clinical profiles and may benefit from specific therapeutic protocols, including consideration for allogeneic stem cell transplantation in appropriate cases."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample received frozen
- Sample collected in incorrect tube type (non-EDTA)
- Sample volume less than 2 mL
- Hemolyzed or severely lipemic sample
- Sample without accompanying clinical history
- Unlabeled or mislabeled sample
- Sample received beyond the stability window
Understanding Your Results
Detected (Positive)
The MLL-ENL fusion gene is present, confirming the diagnosis of MLL-rearranged leukemia (AML or ALL). This result has prognostic significance and influences treatment planning, including consideration for intensive chemotherapy and potential allogeneic stem cell transplantation.
Not Detected (Negative)
The MLL-ENL fusion transcript was not detected in the submitted sample. This does not exclude the possibility of other MLL gene rearrangements or alternative molecular abnormalities. Clinical correlation and additional testing may be warranted.
Inconclusive
The test could not provide a definitive result due to sample quality issues, insufficient DNA, or presence of PCR inhibitors. A repeat sample may be required for retesting.
Consult your oncologist or hematologist if you experience persistent fatigue, unexplained bruising or bleeding, recurrent infections, fever, shortness of breath, swollen lymph nodes, or unexplained weight loss. If you have been diagnosed with leukemia, discuss with your doctor whether this molecular test is appropriate as part of your diagnostic workup. Early consultation is essential as MLL-rearranged leukemias may require urgent and specific treatment strategies.
Limitations
- ⚠This is a qualitative test and does not quantify the fusion transcript level
- ⚠A negative result does not completely rule out the presence of other MLL gene rearrangements
- ⚠The test is designed to detect the MLL-ENL fusion specifically and will not detect other MLL fusion partners
- ⚠False negatives may occur if the fusion transcript is present below the analytical sensitivity threshold of the assay
- ⚠Clinical correlation with morphological, immunophenotypic, and cytogenetic findings is essential for comprehensive diagnosis
Risks & Considerations
- ●Minor bruising or discomfort at the venipuncture site
- ●Rarely, infection at the needle insertion site
- ●If bone marrow collection is performed, there may be localized pain, bleeding, or infection at the aspiration site
- ●Emotional distress related to test results – counseling support is recommended
Interfering Factors
- ●Hemolyzed or degraded sample may affect DNA quality and test reliability
- ●Insufficient sample volume may lead to inconclusive results
- ●Improper storage or shipping conditions (freezing of the sample is not acceptable)
- ●Contamination during sample collection or transport
- ●Recent blood transfusion may dilute the leukemic clone and affect detection sensitivity
Compare With Similar Tests
| Test | t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test | MLL-ENL PCR Qualitative Test | MLL Gene Rearrangement FISH Panel | BCR-ABL1 PCR Qualitative Test |
|---|---|---|---|---|
| Comparison | t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test |
Frequently Asked Questions
What is the t(11;19) (q23;p13.3) (MLL-ENL) PCR Qualitative Test?
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Is fasting required before this test?
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How much does this test cost at DNA Labs India?
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