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t(12;21) (p13;q22) ETV6-RUNX1 (TEL-AML1) PCR Qualitative Test

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t(12;21) (p13;q22) ETV6-RUNX1 (TEL-AML1) PCR Qualitative Test

Short Name: ETV6-RUNX1 PCR Test

Also known as: TEL-AML1 PCR Test, ETV6-RUNX1 Fusion Gene Test, t(12;21) Translocation PCR

t(12;21) (p13;q22) ETV6-RUNX1 (TEL-AML1) PCR Qualitative Test test available at DNA Labs India for ₹5,000. Uses Real Time PCR on Whole Blood or Bone Marrow samples. Results in Reports are typically available within 2-3 working days after sample receipt. Online access is provided via portal, email, or WhatsApp.. Free home collection in 300+ cities across India.

PCR Qualitative TestAll ages, common in children🏠 Home Collection

✍️ Written By

🩺 Medically Reviewed By

Dr Pasupathy Arumugam

Dr Pasupathy Arumugam

Consultant Pathologist · Reg: 21521

Last reviewed: September 7, 2026

Overview

The primary purpose of the ETV6-RUNX1 PCR Qualitative Test is to detect the specific genetic translocation t(12;21)(p13;q22) that leads to the ETV6-RUNX1 fusion gene. This fusion gene is a hallmark of a subtype of Acute Lymphoblastic Leukemia (ALL), which accounts for a significant proportion of childhood leukemia cases. By identifying this genetic marker, the test aids in confirming the diagnosis of ALL, differentiating it from other types of leukemia, and providing prognostic information. The presence of ETV6-RUNX1 is generally associated with a favorable outcome, guiding treatment decisions and reducing the need for more aggressive therapies. Additionally, the test can be used for minimal residual disease monitoring during and after treatment to assess treatment efficacy and detect early relapse.

Test Code
1430
Price
₹5,000
Sample Type
Whole Blood or Bone Marrow
Result Time
Reports are typically available within 2-3 working days after sample receipt. Online access is provided via portal, email, or WhatsApp.
Fasting Required
No
Method
Real Time PCR
Step 1

Sample Collection

No specific preparation such as fasting is required. However, providing complete clinical history, including symptoms, family history, and previous test results, is mandatory. Inform the healthcare provider about any medications or recent procedures.

Method: Venipuncture or Bone Marrow Aspiration

Step 2

Laboratory Analysis

A healthcare professional will collect the sample via venipuncture for blood or bone marrow aspiration. The procedure is minimally invasive for blood draw; bone marrow collection may involve local anesthesia. Patients may experience slight discomfort or bruising.

Step 3

Report Delivery

Apply pressure to the puncture site to prevent bleeding. For bone marrow samples, avoid strenuous activity for a day. Store the sample as instructed: refrigerate and do not freeze. The sample is shipped to the laboratory for analysis.

Timeline: Reports are typically available within 2-3 working days after sample receipt. Online access is provided via portal, email, or WhatsApp.

Patient Instructions

1
Before the Test:Provide clinical history, including symptoms and previous diagnoses. No fasting required. Ensure proper sample collection as per guidelines.
2
During the Test:Sample is processed in the laboratory using Real Time PCR. The test amplifies DNA to detect the ETV6-RUNX1 fusion gene.
3
After the Test:Results are available online. Discuss findings with your healthcare provider. Retain report for future reference.

About This Test

Who Should Get This Test

The primary purpose of the ETV6-RUNX1 PCR Qualitative Test is to detect the specific genetic translocation t(12;21)(p13;q22) that leads to the ETV6-RUNX1 fusion gene. This fusion gene is a hallmark of a subtype of Acute Lymphoblastic Leukemia (ALL), which accounts for a significant proportion of childhood leukemia cases. By identifying this genetic marker, the test aids in confirming the diagnosis of ALL, differentiating it from other types of leukemia, and providing prognostic information. The presence of ETV6-RUNX1 is generally associated with a favorable outcome, guiding treatment decisions and reducing the need for more aggressive therapies. Additionally, the test can be used for minimal residual disease monitoring during and after treatment to assess treatment efficacy and detect early relapse.

How to Prepare

  • Collect 3 mL (minimum 2 mL) of whole blood or bone marrow in a Lavender Top (EDTA) tube
  • Ship the sample refrigerated; do not freeze
  • Include clinical history and patient details on the requisition form
  • Ensure proper labeling to avoid sample mix-ups
  • Process the sample within stability limits: room temperature up to 6 hours, refrigerated up to 72 hours

Doctor's Notes

Reviewed by — MBBS, MD (Pathology) · Reg. No. 21521

"This test is crucial for diagnosing a common subtype of childhood Acute Lymphoblastic Leukemia (ALL) with a favorable prognosis, aiding in targeted treatment planning."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeWhole Blood or Bone Marrow
Sample Volume3 mL (2 mL min.)
ContainerLavender Top (EDTA) tube
Collection MethodVenipuncture or Bone Marrow Aspiration

Sample Stability

Room Temperature6 hours
Refrigerator72 hours
FrozenNot Applicable
Sample Rejection Criteria:
  • Hemolyzed, clotted, or insufficient sample volume
  • Incorrect container or anticoagulant
  • Sample received frozen or past stability period
  • Missing clinical history or patient identification
  • Contaminated or unlabeled samples

Understanding Your Results

Results of the ETV6-RUNX1 PCR Qualitative Test indicate the presence or absence of the fusion gene. Interpretation should be done by a qualified healthcare professional in the context of clinical presentation and other laboratory findings.
📊

Positive

Detection of the ETV6-RUNX1 fusion gene, confirming the diagnosis of a subtype of B-cell ALL associated with a favorable prognosis. Requires further clinical correlation and treatment planning.

Action: Consult an oncologist for comprehensive management.

📊

Negative

No detection of the ETV6-RUNX1 fusion gene. This does not rule out ALL, as other genetic abnormalities may be present. Consider additional tests if clinical suspicion remains high.

Action: Discuss with physician for further evaluation, such as cytogenetics or FISH testing.

⚠️ When to Consult a Doctor:

Consult a doctor immediately if you experience symptoms of leukemia such as persistent fever, fatigue, bone pain, easy bruising, or unexplained weight loss. If the test result is positive or uncertain, seek guidance from an oncologist for diagnosis and treatment. Regular follow-up is essential for monitoring after a diagnosis.

Limitations

  • ⚠This test only detects the ETV6-RUNX1 fusion gene and may not identify other genetic abnormalities in ALL
  • ⚠Qualitative results do not quantify the fusion gene level
  • ⚠False negatives can occur if the fusion gene is present below the detection limit
  • ⚠Not suitable for detecting other translocations like t(9;22) or t(1;19)
  • ⚠Results should be interpreted in conjunction with clinical findings and other diagnostic tests

Risks & Considerations

  • ●Minimal risks associated with blood draw: pain, bruising, or infection at puncture site
  • ●For bone marrow aspiration: soreness, bleeding, or rare complications like infection
  • ●No direct risks from the PCR test itself

Interfering Factors

  • ●Sample contamination or improper handling
  • ●Degraded DNA due to delayed processing
  • ●Hemolyzed or lipemic blood samples
  • ●Recent blood transfusions may affect DNA quality
  • ●Incorrect sample type or volume

Compare With Similar Tests

Testt(12;21) (p13;q22) ETV6-RUNX1 (TEL-AML1) PCR Qualitative TestFluorescence In Situ Hybridization (FISH) for t(12;21)KaryotypingBCR-ABL PCR TestFlow Cytometry for ALL
Comparisont(12;21) (p13;q22) ETV6-RUNX1 (TEL-AML1) PCR Qualitative Test

Frequently Asked Questions

What is the ETV6-RUNX1 PCR test used for?
It is used to detect the t(12;21) translocation resulting in the ETV6-RUNX1 fusion gene, which is a marker for a subtype of Acute Lymphoblastic Leukemia (ALL), primarily in children.
How is the test performed?
The test uses Real Time PCR on DNA extracted from blood or bone marrow samples to qualitatively detect the fusion gene.
What is the cost of the ETV6-RUNX1 PCR test in India?
The cost is INR 5000, with free home sample collection available across India through DNA Labs India.
Is fasting required for this test?
No, fasting is not required. However, providing clinical history is mandatory.
What sample is needed for the test?
3 mL of whole blood or bone marrow in an EDTA (lavender top) tube is required.
How long does it take to get the results?
Results are typically available within 2-3 working days after sample collection.
What does a positive result mean?
A positive result indicates the presence of the ETV6-RUNX1 fusion gene, confirming a subtype of ALL with generally favorable prognosis.
What if the test is negative?
A negative result means the fusion gene was not detected. However, ALL may still be present due to other genetic abnormalities; consult your doctor for further tests.
Is the test accurate?
Yes, PCR is highly sensitive and specific for detecting the ETV6-RUNX1 fusion gene when performed in accredited laboratories like DNA Labs India.
Can this test be used for monitoring treatment?
Yes, it can be used for minimal residual disease monitoring to assess treatment response and detect relapse early.
Are there any risks associated with the test?
The risks are minimal, limited to those from sample collection, such as bruising or infection. The PCR process itself is non-invasive.
Which cities offer home sample collection for this test?
Home collection is available in major cities across India, including Mumbai, Delhi, Bangalore, Hyderabad, Chennai, Kolkata, and many more as listed by DNA Labs India.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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We serve as a reference laboratory for hospitals and clinics across India. Send samples from your facility with same-day pickup, priority processing, and results delivered through our online portal. Competitive institutional pricing available.

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