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BCR-ABL1 Quantification by DD PCR Test

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BCR-ABL1 Quantification by DD PCR Test

Short Name: BCR-ABL1 DD PCR

Also known as: BCR-ABL1 Kinase Domain Mutation Analysis, BCR-ABL1 Mutation Testing, IRMA

BCR-ABL1 Quantification by DD PCR Test test available at DNA Labs India for ₹15,000. Uses Next Generation Sequencing (NGS), Droplet Digital PCR (DD-PCR) on Bone marrow / Peripheral blood samples. Results in Reports are typically available within 2-3 weeks after the sample is received at the laboratory.. Free home collection in 300+ cities across India.

Molecular🏠 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 BCR-ABL1 Quantification by DD PCR test is to: 1) Diagnose CML by detecting the BCR-ABL1 fusion gene. 2) Monitor the molecular response to TKI therapy by quantifying BCR-ABL1 transcript levels. 3) Identify kinase domain mutations that confer resistance to TKIs, guiding treatment decisions. 4) Detect minimal residual disease (MRD) with high sensitivity. 5) Predict disease progression and relapse. This test is essential for personalized management of CML patients.

Test Code
6048
CPT Code
81206
ICD Code
C92.1
Price
₹15,000
Sample Type
Bone marrow / Peripheral blood
Result Time
Reports are typically available within 2-3 weeks after the sample is received at the laboratory.
Fasting Required
No
Method
Next Generation Sequencing (NGS), Droplet Digital PCR (DD-PCR)
Step 1

Sample Collection

No special preparation is required. However, a doctor's prescription is mandatory. Inform your physician about any ongoing medications, especially TKIs, as they may affect test results.

Method: Venipuncture or bone marrow aspiration

Step 2

Laboratory Analysis

Blood sample will be collected by venipuncture. For bone marrow, a specialist will perform the aspiration under sterile conditions. The procedure is generally safe and takes a few minutes.

Step 3

Report Delivery

You can resume normal activities immediately. There may be minor bruising at the puncture site, which is normal. For bone marrow, you may experience soreness for a few days; follow your doctor's advice.

Timeline: Reports are typically available within 2-3 weeks after the sample is received at the laboratory.

Patient Instructions

1
Before the Test:No special preparation is needed. Ensure you have a doctor's prescription. Inform your doctor about all medications you are taking.
2
During the Test:A blood sample will be drawn from a vein in your arm. If bone marrow is required, a small procedure will be performed by a specialist. You may feel slight discomfort but it is generally well-tolerated.
3
After the Test:You can return to normal activities. For bone marrow, you may have some soreness; follow your doctor's instructions. Results will be available in 2-3 weeks.

About This Test

Who Should Get This Test

The primary purpose of the BCR-ABL1 Quantification by DD PCR test is to: 1) Diagnose CML by detecting the BCR-ABL1 fusion gene. 2) Monitor the molecular response to TKI therapy by quantifying BCR-ABL1 transcript levels. 3) Identify kinase domain mutations that confer resistance to TKIs, guiding treatment decisions. 4) Detect minimal residual disease (MRD) with high sensitivity. 5) Predict disease progression and relapse. This test is essential for personalized management of CML patients.

How to Prepare

  • Use EDTA vacutainer for blood sample.
  • Transport the sample immediately to the laboratory at 2-8°C (cool pack).
  • Do not freeze the sample.
  • Label the sample with patient details and date of collection.
  • For bone marrow, ensure proper handling and transport as per laboratory guidelines.

Doctor's Notes

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

"BCR-ABL1 kinase domain mutation analysis is essential for managing CML patients who develop resistance to tyrosine kinase inhibitors. Early detection of mutations allows for timely therapeutic adjustments, improving patient outcomes."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeBone marrow / Peripheral blood
Sample Volume2 ml (EDTA) or as required
ContainerEDTA Vacutainer (2ml)
Collection MethodVenipuncture or bone marrow aspiration

Sample Stability

Whole blood: 24 hours at 2-8°C
Bone marrow: 24 hours at 2-8°C
Extracted RNA: 1 week at -20°C
Sample Rejection Criteria:
  • Clotted or hemolyzed sample.
  • Incorrect anticoagulant (e.g., heparin).
  • Sample received after 48 hours without proper storage.
  • Unlabeled or mislabeled sample.
  • Insufficient sample volume.

Understanding Your Results

The BCR-ABL1 Quantification by DD PCR test provides crucial information for managing CML. The results are interpreted based on the presence of the BCR-ABL1 fusion gene and the detection of kinase domain mutations.
📊

Indicates no known TKI resistance mutations. Patient is likely to respond to standard TKI therapy.

📊

Specific mutations may confer resistance to certain TKIs. For example, T315I is resistant to imatinib, dasatinib, and nilotinib, but may respond to ponatinib. Treatment should be adjusted accordingly.

📊

Indicates residual disease or suboptimal molecular response. May require dose adjustment or change of therapy.

📊

Major molecular response (MMR) achieved, indicating good response to therapy.

⚠️ When to Consult a Doctor:

Consult your oncologist if you experience symptoms such as persistent fatigue, unexplained weight loss, night sweats, abdominal fullness, or bone pain. Also, if you are undergoing CML treatment and have concerns about drug resistance or disease progression, discuss the need for this test with your doctor.

Limitations

  • ⚠Mutations may not be detected if the clone is below the limit of detection.
  • ⚠Test does not cover all possible kinase domain mutations; only those in the tested region.
  • ⚠Results should be interpreted in conjunction with clinical and hematological findings.
  • ⚠Not a standalone diagnostic test for CML; requires correlation with CBC and bone marrow biopsy.

Risks & Considerations

  • ●Minor bleeding or bruising at the puncture site.
  • ●Infection (rare) at the site of bone marrow aspiration.
  • ●Discomfort during bone marrow procedure.

Interfering Factors

  • ●Sample degradation due to delayed processing or improper storage.
  • ●Low RNA quality or quantity.
  • ●Presence of inhibitors in the sample.
  • ●Contamination with normal cells.
  • ●Prior treatment with TKIs may reduce mutation detection sensitivity.

Compare With Similar Tests

TestBCR-ABL1 Quantification by DD PCRCytogenetic Analysis (Philadelphia Chromosome)FISH (Fluorescence In Situ Hybridization)RT-PCR (Qualitative)
ComparisonBCR-ABL1 Quantification by DD PCR

Frequently Asked Questions

What is the cost of BCR-ABL1 Quantification by DD PCR?
The cost is INR 15,000 at DNA Labs India, which includes home sample collection and report delivery.
What is the purpose of this test?
It is used to diagnose CML, monitor treatment response, and detect mutations that cause resistance to TKIs.
What sample is required?
Peripheral blood (2 ml in EDTA) or bone marrow sample is required.
Do I need to fast before the test?
No, fasting is not required for this test.
How long does it take to get results?
Results are typically available within 2-3 weeks after sample collection.
Is home sample collection available?
Yes, we offer free home sample collection for online bookings across major cities in India.
What is the significance of kinase domain mutations?
Mutations in the BCR-ABL1 kinase domain can cause resistance to TKIs, leading to treatment failure. Identifying them helps in selecting alternative therapies.
Can this test be done without a doctor's prescription?
No, a doctor's prescription is required for this test, except for surgery, pregnancy, or travel purposes.
What is the difference between DD-PCR and conventional PCR?
DD-PCR provides absolute quantification with higher sensitivity and precision compared to conventional PCR.
Are there any risks associated with the test?
The test is safe. For blood sample, minor bruising may occur. For bone marrow, there is a small risk of infection or bleeding.
What does a 'no mutation detected' result mean?
It means no known TKI resistance mutations were found, indicating likely response to standard TKI therapy.
How should I prepare for the test?
No special preparation is needed. Ensure you have a doctor's prescription and inform your doctor about any medications you are taking.
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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