Chronic Lymphocytic Leukemia (CLL) Mutations Detection Panel 2 Test
Short Name: CLL Mutations Panel 2
Also known as: CLL Panel 2 Test, CLL Genetic Mutation Test, CLL Molecular Profiling Test, Leukemia Mutations Detection Panel, CLL Prognostic Panel
Chronic Lymphocytic Leukemia (CLL) Mutations Detection Panel 2 Test test available at DNA Labs India for ₹5,000. Uses PCR (Polymerase Chain Reaction), MLPA (Multiplex Ligation-dependent Probe Amplification) on Whole Blood samples. Results in Sample should be received by Monday 11:00 AM. Report is typically available by Saturday of the same week. Digital reports are delivered via Online Portal, Email, and WhatsApp.. 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 CLL Mutations Detection Panel 2 Test is performed to identify specific genetic mutations and chromosomal abnormalities associated with Chronic Lymphocytic Leukemia. The primary purposes include: (1) Prognostic risk stratification to categorise patients into low-risk, intermediate-risk, or high-risk groups; (2) Identification of mutations that predict resistance or sensitivity to specific therapies, enabling personalised treatment selection; (3) Detection of clonal evolution at relapse to guide second-line treatment decisions; (4) Monitoring disease progression and informing the timing of treatment initiation; (5) Providing information for clinical trial eligibility assessment.
- Test Code
- 323
- CPT Code
- 81245
- ICD Code
- C91.10
- Price
- ₹5,000
- Sample Type
- Whole Blood
- Result Time
- Sample should be received by Monday 11:00 AM. Report is typically available by Saturday of the same week. Digital reports are delivered via Online Portal, Email, and WhatsApp.
- Fasting Required
- No
- Method
- PCR (Polymerase Chain Reaction), MLPA (Multiplex Ligation-dependent Probe Amplification)
Sample Collection
Ensure the Genomics Clinical Information Requisition Form (Form 20) is duly filled and accompanies the sample. No fasting is required. Inform the phlebotomist about any recent blood transfusions or ongoing treatments. Maintain the sample at room temperature (up to 6 hours) or refrigerated (up to 72 hours) before dispatch. Do NOT freeze the sample.
Method: Venipuncture
Laboratory Analysis
Collect 4 mL (minimum 2 mL) of whole blood via venipuncture into a Lavender top (EDTA) tube. Gently invert the tube 8–10 times to ensure proper mixing with the anticoagulant. Label the tube clearly with the patient's name, date of collection, and unique identification number.
Report Delivery
Ship the sample refrigerated (2–8°C). Do NOT freeze. Ensure the sample reaches the laboratory within the stability window. The duly filled Genomics Clinical Information Requisition Form (Form 20) must accompany every sample. Reports are typically available by Saturday for samples received by Monday 11 AM.
Timeline: Sample should be received by Monday 11:00 AM. Report is typically available by Saturday of the same week. Digital reports are delivered via Online Portal, Email, and WhatsApp.
Patient Instructions
About This Test
Who Should Get This Test
The CLL Mutations Detection Panel 2 Test is performed to identify specific genetic mutations and chromosomal abnormalities associated with Chronic Lymphocytic Leukemia. The primary purposes include: (1) Prognostic risk stratification to categorise patients into low-risk, intermediate-risk, or high-risk groups; (2) Identification of mutations that predict resistance or sensitivity to specific therapies, enabling personalised treatment selection; (3) Detection of clonal evolution at relapse to guide second-line treatment decisions; (4) Monitoring disease progression and informing the timing of treatment initiation; (5) Providing information for clinical trial eligibility assessment.
How to Prepare
- Collect 4 mL (minimum 2 mL) whole blood in a Lavender top (EDTA) tube
- Gently invert the EDTA tube 8–10 times immediately after collection
- Label the specimen with patient name, date, and unique ID
- Duly filled Genomics Clinical Information Requisition Form (Form 20) is mandatory
- Ship refrigerated (2–8°C); do NOT freeze
- Sample stability: Room Temperature up to 6 hours, Refrigerated up to 72 hours
Doctor's Notes
Reviewed by Dr SULOCHANA HEMCHANDRA HOLLA — MBBS, MD (Medical Genetics) · Reg. No. 8532
"The CLL Mutations Detection Panel 2 is an essential prognostic and therapeutic-guiding tool in the management of Chronic Lymphocytic Leukemia. Mutations such as TP53/17p deletion are associated with resistance to conventional chemoimmunotherapy and guide the use of targeted agents like BTK inhibitors or BCL-2 inhibitors. Similarly, NOTCH1 and SF3B1 mutations carry prognostic significance that influences treatment intensity and monitoring frequency. I recommend this panel for all newly diagnosed CLL patients and at relapse to reassess clonal evolution and optimize treatment strategy."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample received without duly filled Genomics Clinical Information Requisition Form (Form 20)
- Frozen whole blood sample
- Haemolysed, clotted, or insufficient volume sample
- Sample received beyond the stability window (room temperature >6 hours or refrigerated >72 hours)
- Incorrect sample type (non-EDTA tube)
- Unlabelled or mislabelled specimen
Understanding Your Results
High-risk CLL. Associated with aggressive disease, poor response to chemoimmunotherapy, and shorter overall survival. Targeted therapies such as BTK inhibitors (e.g., ibrutinib, acalabrutinib) or BCL-2 inhibitors (e.g., venetoclax) are recommended. Urgent haematologist/oncologist consultation advised.
Intermediate to high-risk CLL. Associated with bulky lymphadenopathy, rapid disease progression, and shorter treatment-free survival. Close monitoring and early consideration of targeted therapy is recommended.
Low-risk CLL. Generally associated with favourable prognosis, longer time to first treatment, and overall better survival outcomes. Watch-and-wait approach is typically appropriate.
Intermediate-risk CLL. May be associated with atypical morphology. When co-occurring with NOTCH1 mutations, the prognosis may be less favourable. Treatment decisions should consider the full mutation profile.
Intermediate-risk CLL. Associated with fludarabine resistance and may influence the choice of targeted therapy. Regular monitoring of disease progression is recommended.
Generally associated with favourable prognosis in CLL. However, the presence of MYD88 L265P in the context of other adverse mutations should be evaluated comprehensively.
Intermediate to high-risk marker. Associated with reduced response to anti-CD20 monoclonal antibodies and may predict shorter overall survival. Consider targeted therapy approaches.
Loss of PTEN leads to activation of the PI3K/AKT survival pathway. May influence response to PI3K inhibitors and warrants consideration in treatment planning.
No targeted mutations or chromosomal abnormalities detected by this panel. This does not exclude CLL diagnosis if clinical and immunophenotypic criteria are met. Additional molecular testing or comprehensive genomic profiling may be considered if clinically indicated.
Consult your haematologist or oncologist if you experience persistent enlarged lymph nodes, unexplained fatigue, night sweats, unintentional weight loss, frequent infections, or if you have an unexplained elevated lymphocyte count on routine blood work. If you have been diagnosed with CLL, discuss with your treating physician whether this mutation panel is appropriate for your disease stage and treatment planning. Results of this test should always be interpreted by a qualified medical professional who can correlate findings with your clinical status.
Limitations
- ⚠This panel targets specific known mutations and chromosomal regions; novel or rare mutations outside the panel scope will not be detected
- ⚠Low-level mosaicism below the analytical sensitivity threshold of the assay may not be identified
- ⚠Results should always be interpreted in conjunction with clinical presentation, complete blood count, flow cytometry, bone marrow findings, and other relevant investigations
- ⚠The test does not replace comprehensive cytogenetic analysis (FISH panel) or next-generation sequencing for complete genomic profiling
- ⚠Detection of a mutation does not in itself indicate the need for treatment; clinical correlation is essential
Risks & Considerations
- ●Minimal risk associated with routine venipuncture, including slight bruising or discomfort at the collection site
- ●Very rare risk of infection at the needle insertion site
- ●Genetic test results may cause emotional distress; genetic counselling support is available on request
- ●Results may have implications for insurance and family planning; discuss with your physician
Interfering Factors
- ●Recent blood transfusions may affect the proportion of CLL cells in the sample
- ●Sample haemolysis or clotting may compromise DNA quality and test accuracy
- ●Insufficient sample volume may lead to inadequate DNA extraction
- ●Delay in sample processing beyond stability window may degrade nucleic acids
- ●Concurrent chemotherapy or targeted therapy may alter clonal proportions and affect mutation detection sensitivity
Compare With Similar Tests
| Test | Chronic Lymphocytic Leukemia (CLL) Mutations Detection Panel 2 Test | CLL FISH Panel | Next-Generation Sequencing (NGS) for CLL | Flow Cytometry for CLL | Beta-2 Microglobulin Test |
|---|---|---|---|---|---|
| Comparison | Chronic Lymphocytic Leukemia (CLL) Mutations Detection Panel 2 Test | The FISH panel detects chromosomal abnormalities using fluorescence in situ hybridisation and requires viable cells. The CLL Mutations Panel 2 uses PCR and MLPA on extracted DNA, offering detection of both point mutations and copy number changes from a standard EDTA blood sample. | NGS provides comprehensive genomic profiling of hundreds of genes simultaneously and may detect novel or rare mutations. The CLL Mutations Panel 2 targets a focused set of clinically validated mutations and chromosomal regions, offering faster turnaround and lower cost. | Flow cytometry is used for immunophenotypic diagnosis and minimal residual disease (MRD) monitoring in CLL. The Mutations Panel 2 complements flow cytometry by providing molecular and cytogenetic information for prognosis and therapy selection. | Beta-2 microglobulin is a serum biomarker used for CLL staging and prognosis. It provides staging information but lacks the molecular specificity of the Mutations Panel 2, which identifies actionable genetic targets for personalised therapy. |
Frequently Asked Questions
What is the CLL Mutations Detection Panel 2 Test?
Who should take the CLL Mutations Detection Panel 2 Test?
What sample is required for the CLL Mutations Detection Panel 2 Test?
How much does the CLL Mutations Detection Panel 2 Test cost at DNA Labs India?
What is the turnaround time for the CLL Mutations Detection Panel 2 Test results?
What does it mean if 17p deletion is detected in my CLL Mutations Panel?
What is the difference between CLL Mutations Panel 1 and Panel 2?
Is fasting required before the CLL Mutations Detection Panel 2 Test?
Is home sample collection available for the CLL Mutations Panel 2 Test?
Can this test be used to monitor CLL disease progression?
What if all parameters in the CLL Mutations Panel are normal or not detected?
Does the CLL Mutations Detection Panel 2 Test require a special requisition form?
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