BCR-ABL Gene Rearrangement PCR Quantitative Test
Short Name: BCR-ABL Quantitative PCR
Also known as: Philadelphia Chromosome PCR Quantitative, BCR-ABL1 Quantitative RT-PCR, BCR-ABL Molecular Monitoring Test, CML Molecular Response Test, t(9;22) Translocation Quantitative PCR
BCR-ABL Gene Rearrangement PCR Quantitative Test test available at DNA Labs India for ₹7,500. Uses Real-Time Quantitative PCR (RT-qPCR) on Whole Blood / Bone Marrow samples. Results in Sample must be received daily by 9:00 AM. Report available the same day.. 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 BCR-ABL Gene Rearrangement PCR Quantitative Test is to detect and measure the level of BCR-ABL1 fusion gene transcripts in patients suspected of or being treated for Chronic Myeloid Leukemia (CML) or Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This test serves multiple clinical purposes: confirming the molecular diagnosis of CML at presentation, monitoring the effectiveness of tyrosine kinase inhibitor (TKI) therapy by tracking molecular response milestones (MR3, MR4, MR4.5), detecting early signs of treatment failure or disease relapse, and evaluating eligibility for treatment-free remission (TFR) in patients with sustained deep molecular response.
- Test Code
- 204
- CPT Code
- 81206
- ICD Code
- C92.1
- Price
- ₹7,500
- Sample Type
- Whole Blood / Bone Marrow
- Result Time
- Sample must be received daily by 9:00 AM. Report available the same day.
- Fasting Required
- No
- Method
- Real-Time Quantitative PCR (RT-qPCR)
Sample Collection
No special preparation or fasting is required. Inform your physician about all current medications, especially tyrosine kinase inhibitors. Ensure the sample is collected before the daily dose of TKI medication for consistent monitoring.
Method: Venipuncture / Bone Marrow Aspiration
Laboratory Analysis
A blood sample of 5 mL (minimum 3 mL) will be drawn from a vein in your arm via standard venipuncture. Alternatively, a bone marrow aspirate sample may be collected by your treating physician. The blood draw procedure takes approximately 5–10 minutes. The sample is transferred immediately into a Lavender Top (EDTA) tube and gently mixed.
Report Delivery
You may resume normal activities immediately after blood collection. Mild soreness or bruising at the puncture site is common and typically resolves within a few hours. Apply gentle pressure to the site. Results will be available the same day if the sample reaches the laboratory before 9:00 AM.
Timeline: Sample must be received daily by 9:00 AM. Report available the same day.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of the BCR-ABL Gene Rearrangement PCR Quantitative Test is to detect and measure the level of BCR-ABL1 fusion gene transcripts in patients suspected of or being treated for Chronic Myeloid Leukemia (CML) or Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This test serves multiple clinical purposes: confirming the molecular diagnosis of CML at presentation, monitoring the effectiveness of tyrosine kinase inhibitor (TKI) therapy by tracking molecular response milestones (MR3, MR4, MR4.5), detecting early signs of treatment failure or disease relapse, and evaluating eligibility for treatment-free remission (TFR) in patients with sustained deep molecular response.
How to Prepare
- Collect sample in a Lavender Top (EDTA) tube only
- Minimum volume required: 3 mL (5 mL preferred)
- Gently invert the tube 8–10 times immediately after collection
- Ship the sample refrigerated (2–8°C); do not freeze
- Sample must reach the laboratory within 4 days of collection
- Label the tube clearly with patient name, date of birth, and collection date/time
- Use free home collection service available through DNA Labs India online booking
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"Quantitative BCR-ABL1 monitoring using RT-qPCR on the International Scale is the gold standard for assessing molecular response in CML patients on tyrosine kinase inhibitor (TKI) therapy. Achieving a Major Molecular Response (MR3, ≤0.1% IS) by 12 months is a strong predictor of long-term favorable outcomes. Serial monitoring every 3 months allows early detection of treatment failure or loss of response, enabling timely therapeutic adjustments. For patients who achieve sustained deep molecular response (MR4 or MR4.5), treatment-free remission may be considered under close supervision."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample collected in incorrect tube type (non-EDTA)
- Frozen or previously frozen samples
- Insufficient sample volume (less than 3 mL)
- Severely hemolyzed, clotted, or contaminated samples
- Unlabeled or mislabeled samples
- Samples received at room temperature after 24 hours of collection
Understanding Your Results
No BCR-ABL1 fusion transcript detected. In healthy individuals, this is the expected result. In treated CML patients, this indicates a Complete Molecular Response (CMR) or undetectable minimal residual disease.
Major Molecular Response achieved. The disease burden is very low. This milestone is typically targeted by 12 months of TKI therapy and is associated with excellent long-term outcomes.
Suboptimal molecular response. The patient may not have achieved MR3 or may be losing a previously achieved response. Close monitoring at shorter intervals and clinical review are recommended.
Warning level. Indicates incomplete response to treatment or early treatment failure. Adherence assessment, mutation analysis, and possible treatment change should be considered.
Treatment failure. Significant disease burden detected. Urgent clinical evaluation, BCR-ABL1 kinase domain mutation testing, and change of therapy are recommended per ELN/NCCN guidelines.
Consult your hematologist or oncologist immediately if your BCR-ABL1 levels show a rising trend over consecutive tests, if molecular response milestones are not being achieved at expected time points, if you experience new or worsening symptoms such as persistent fatigue, unexplained weight loss, drenching night sweats, left upper abdominal fullness or pain, easy bruising or bleeding, recurrent infections, or bone pain. Also seek medical advice if you are considering stopping TKI therapy.
Limitations
- ⚠This test detects only BCR-ABL1 fusion transcripts; it cannot identify chromosomal abnormalities other than t(9;22)
- ⚠False-negative results are possible if BCR-ABL1 transcript levels fall below the analytical sensitivity of the assay
- ⚠Does not replace conventional cytogenetic analysis (karyotyping) for complete assessment of additional chromosomal abnormalities
- ⚠ABL1 kinase domain mutations conferring TKI resistance are not detected by this test; a separate mutation analysis is required
- ⚠Results should always be interpreted in conjunction with clinical findings, CBC reports, and bone marrow morphology
Risks & Considerations
- ●Minor bruising or soreness at the blood draw site
- ●Rarely, slight swelling or infection at the puncture site
- ●If bone marrow aspiration is performed, localized pain and minor bleeding may occur at the collection site
- ●No significant risks are associated with the PCR laboratory procedure itself
Interfering Factors
- ●Hemolyzed or lipemic blood samples may degrade RNA quality and affect results
- ●Delayed sample processing or improper storage temperatures can cause RNA degradation
- ●Contamination from prior PCR products may lead to false-positive results
- ●Very low transcript levels near the assay detection limit may produce variable results
- ●Prior blood transfusions within 24 hours may dilute the patient's own BCR-ABL positive cells
Compare With Similar Tests
| Test | BCR-ABL Gene Rearrangement PCR Quantitative Test | BCR-ABL FISH (Fluorescence In Situ Hybridization) | Conventional Cytogenetics (Karyotyping) | BCR-ABL Qualitative PCR |
|---|---|---|---|---|
| Comparison | BCR-ABL Gene Rearrangement PCR Quantitative Test | FISH detects the Philadelphia chromosome at the chromosomal/cellular level and is useful at initial diagnosis. However, it is less sensitive than quantitative PCR for monitoring low-level residual disease. RT-qPCR can detect 1 BCR-ABL positive cell among 100,000–1,000,000 normal cells, making it the preferred method for treatment monitoring. | Karyotyping provides a comprehensive view of all chromosomal abnormalities and can detect additional cytogenetic changes that may influence prognosis. However, it requires dividing cells and has lower sensitivity (~5%) compared to RT-qPCR. It is recommended at diagnosis but not for routine monitoring. | Qualitative PCR confirms the presence or absence of BCR-ABL1 fusion transcript but does not measure the level. The quantitative PCR test is essential for treatment monitoring as it tracks changes in disease burden over time. |
Frequently Asked Questions
What is the BCR-ABL Gene Rearrangement PCR Quantitative Test?
Why is the BCR-ABL quantitative test important for CML patients?
What does a positive BCR-ABL test result mean?
What is the International Scale (IS) and why is it used?
How is the BCR-ABL PCR quantitative test different from FISH testing?
How often should BCR-ABL levels be monitored during treatment?
Is fasting required for the BCR-ABL PCR test?
What is the cost of the BCR-ABL Gene Rearrangement PCR Quantitative Test in India?
What sample is required for the test and how is it collected?
Can this test detect minimal residual disease (MRD)?
What does it mean if my BCR-ABL levels are rising during treatment?
Is the BCR-ABL PCR test covered by insurance or government health schemes in India?
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