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Inv16 (p13q22) / t(1616)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test

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Inv16 (p13q22) / t(1616)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test

Short Name: Inv16 MRD Monitor Test

Also known as: CBFB-MYH11 Fusion Gene Quantitative Test, Inv16 MRD Test, CBFB-MYH11 RQ-PCR Test, AML Minimal Residual Disease Monitor, Chromosome 16 Inversion Gene Rearrangement Test

Inv16 (p13q22) / t(1616)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test test available at DNA Labs India for ₹7,500. Uses Real-Time Quantitative PCR (RQ-PCR) on Whole Blood / Bone Marrow samples. Results in Sample accepted: Monday or Thursday by 11:00 AM. Reports available: Wednesday or Saturday. Digital reports are shared via Online Portal, Email, and WhatsApp.. Free home collection in 300+ cities across India.

Quantitative MRD MonitorAll Ages🏠 Home Collection

✍️ Written By

🩺 Medically Reviewed By

Dr SULOCHANA HEMCHANDRA HOLLA

Dr SULOCHANA HEMCHANDRA HOLLA

Consultant Medical Geneticist · Reg: 8532

Last reviewed: September 7, 2026

Overview

The primary purpose of this test is to monitor Minimal Residual Disease (MRD) in patients diagnosed with Acute Myeloid Leukemia (AML) carrying the inv(16)(p13q22) or t(16;16)(p13q22) chromosomal rearrangement. By quantitatively tracking the CBFB-MYH11 fusion transcript levels over time, clinicians can: (1) evaluate the depth of molecular response to induction and consolidation chemotherapy, (2) detect early molecular relapse before it manifests as hematological relapse, (3) assess eligibility for hematopoietic stem cell transplantation, and (4) make informed decisions regarding treatment intensification, modification, or de-escalation.

Test Code
1130
CPT Code
81206
ICD Code
C92.0
Price
₹7,500
Sample Type
Whole Blood / Bone Marrow
Result Time
Sample accepted: Monday or Thursday by 11:00 AM. Reports available: Wednesday or Saturday. Digital reports are shared via Online Portal, Email, and WhatsApp.
Fasting Required
No
Method
Real-Time Quantitative PCR (RQ-PCR)
Step 1

Sample Collection

Ensure the Duly filled MRD Requisition form (Form 22) with complete historical clinical data is prepared. No fasting is required. Inform the collection center of any recent blood transfusions, as these may affect results.

Method: Venipuncture / Bone Marrow Aspiration

Step 2

Laboratory Analysis

5 mL whole blood (minimum 3 mL) or bone marrow aspirate will be collected in a Lavender Top (EDTA) tube by a trained phlebotomist or hematologist using standard venipuncture or bone marrow aspiration technique.

Step 3

Report Delivery

The sample must be shipped refrigerated (2-8°C). Do not freeze the sample. The tube should be labeled correctly with patient details and accompanied by the completed MRD Requisition form (Form 22).

Timeline: Sample accepted: Monday or Thursday by 11:00 AM. Reports available: Wednesday or Saturday. Digital reports are shared via Online Portal, Email, and WhatsApp.

Patient Instructions

1
Before the Test:No fasting is required. Ensure the MRD Requisition form (Form 22) is fully completed with historical clinical data including prior MRD results, treatment history, and dates of therapy cycles. Carry previous test reports for reference.
2
During the Test:A phlebotomist or hematologist will collect 5 mL of peripheral blood (minimum 3 mL) or bone marrow aspirate into a Lavender Top (EDTA) tube. The procedure typically takes 5-15 minutes for blood collection or 20-30 minutes for bone marrow aspiration.
3
After the Test:After sample collection, slight bruising at the puncture site may occur and typically resolves within a few days. The sample will be transported refrigerated to the laboratory. Results will be available on Wednesday or Saturday depending on the sample submission day (Monday or Thursday respectively).

About This Test

Who Should Get This Test

The primary purpose of this test is to monitor Minimal Residual Disease (MRD) in patients diagnosed with Acute Myeloid Leukemia (AML) carrying the inv(16)(p13q22) or t(16;16)(p13q22) chromosomal rearrangement. By quantitatively tracking the CBFB-MYH11 fusion transcript levels over time, clinicians can: (1) evaluate the depth of molecular response to induction and consolidation chemotherapy, (2) detect early molecular relapse before it manifests as hematological relapse, (3) assess eligibility for hematopoietic stem cell transplantation, and (4) make informed decisions regarding treatment intensification, modification, or de-escalation.

How to Prepare

  • Collect 5 mL (minimum 3 mL) of whole blood or bone marrow aspirate in a Lavender Top (EDTA) tube
  • Do not use heparinized or citrated tubes
  • Ship the sample refrigerated at 2-8°C. DO NOT FREEZE
  • Complete and submit the MRD Requisition form (Form 22) with all historical data
  • Ensure sample reaches the lab on the designated collection days: Monday or Thursday by 11:00 AM
  • Avoid hemodiluted or clotted samples

Doctor's Notes

Reviewed by — MBBS, MD (Medical Genetics) · Reg. No. 8532

"MRD monitoring with the CBFB-MYH11 quantitative assay is essential for patients diagnosed with inv(16) or t(16;16)-associated Acute Myeloid Leukemia. I recommend establishing a baseline at diagnosis, followed by serial monitoring after each chemotherapy cycle and during consolidation therapy. A conversion from negative to positive MRD status is a critical early indicator of molecular relapse and may warrant clinical intervention before overt hematological relapse occurs. This test empowers both the physician and the patient with actionable molecular data to guide timely treatment decisions."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeWhole Blood / Bone Marrow
Sample Volume5 mL (3 mL minimum)
Container1 Lavender Top (EDTA) Tube
Collection MethodVenipuncture / Bone Marrow Aspiration

Sample Stability

Room Temperature
Refrigerated (2-8°C)
Frozen (-20°C or below)
Sample Rejection Criteria:
  • Clotted samples
  • Frozen samples
  • Samples collected in non-EDTA containers
  • Samples without the mandatory MRD Requisition form (Form 22)
  • Insufficient sample volume (less than 3 mL)
  • Hemolyzed or severely lipemic samples
  • Samples received beyond the stability window of 4 days refrigerated

Understanding Your Results

The results of the Inv16 (p13q22) / t(16;16)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test should be interpreted by a qualified oncologist or hematologist in the context of the patient's clinical history, prior treatment, and other laboratory findings. The following guide provides a general framework for understanding results.
📊

CBFB-MYH11 Not Detected

Indicates absence of detectable residual disease carrying the inv(16)/t(16;16) rearrangement within the sensitivity limits of the assay.

📊

CBFB-MYH11 Detected - Low Level

Could indicate early molecular relapse. Consult treating oncologist for possible treatment modification.

📊

CBFB-MYH11 Detected - Rising Trend

A rising MRD trend is a strong predictor of impending hematological relapse. Urgent consultation with treating oncologist is recommended.

📊

ABL1 Not Detected (Invalid Control)

The test result is inconclusive. Repeat sampling is required with a fresh, properly collected sample.

⚠️ When to Consult a Doctor:

Consult your oncologist or hematologist if your MRD status converts from negative to positive, if transcript levels show a rising trend between consecutive tests, or if new symptoms of leukemia such as fatigue, fever, unexplained weight loss, easy bruising, or bleeding develop. Early physician intervention based on MRD changes can significantly improve treatment outcomes.

Limitations

  • ⚠This test specifically detects only the CBFB-MYH11 fusion transcript and does not identify other AML-associated genetic abnormalities
  • ⚠Cannot distinguish between inv(16) and t(16;16) at the molecular level as both produce the same fusion transcript
  • ⚠Results should be interpreted in conjunction with clinical findings, morphological evaluation, and other laboratory parameters
  • ⚠A negative result does not completely exclude the presence of residual leukemic cells below the assay's limit of detection
  • ⚠The test is designed for monitoring purposes and should be interpreted using patient-specific historical baseline data

Risks & Considerations

  • ●Minimal risk from blood collection: slight pain, bruising, or infection at the puncture site
  • ●Bone marrow aspiration (if applicable) may cause temporary discomfort at the aspiration site
  • ●There is a small possibility of false-negative results if disease burden is below the detection limit
  • ●No radiation exposure or contrast agents are involved

Interfering Factors

  • ●Hemodiluted peripheral blood samples may reduce sensitivity
  • ●Sample degradation due to delayed processing or improper storage
  • ●Presence of PCR inhibitors in the sample
  • ●Insufficient sample volume below the minimum requirement of 3 mL
  • ●Extremely low disease burden below the assay's limit of detection

Compare With Similar Tests

TestInv16 (p13q22) / t(1616)(p13q22) Gene Rearrangement Quantitative MRD Monitor TestBCR-ABL1 Quantitative PCRPML-RARA Gene RearrangementAML1-ETO (RUNX1-RUNX1T1) MRD Monitor
ComparisonInv16 (p13q22) / t(1616)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test

Frequently Asked Questions

What is the Inv16 (p13q22) / t(16;16)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test?
This is a molecular diagnostic test that uses Real-Time Quantitative PCR (RQ-PCR) to detect and measure the CBFB-MYH11 fusion gene transcript. This fusion results from a chromosome 16 inversion [inv(16)] or translocation [t(16;16)] and is associated with a specific subtype of Acute Myeloid Leukemia (AML). The test is primarily used to monitor Minimal Residual Disease (MRD) during and after treatment.
Why is the CBFB-MYH11 MRD Monitor Test important for AML patients?
This test allows clinicians to quantitatively track the level of leukemic cells carrying the CBFB-MYH11 fusion over time. It helps evaluate how well treatment is working, detect early molecular relapse before clinical symptoms appear, and guide decisions about treatment continuation, modification, or the need for stem cell transplantation.
What sample is required for this test?
The test requires 5 mL (minimum 3 mL) of whole blood or bone marrow aspirate collected in a Lavender Top (EDTA) tube. A bone marrow sample is often preferred for higher sensitivity. The sample must be shipped refrigerated and must not be frozen.
Is fasting required before sample collection?
No, fasting is not required for this test. However, the Duly filled MRD Requisition form (Form 22) with complete historical clinical data is mandatory for sample acceptance.
What does a positive (detected) result mean?
A positive result means that the CBFB-MYH11 fusion transcript was detected in the sample, indicating the presence of residual leukemic cells carrying the inv(16) or t(16;16) rearrangement. The quantitative level and trend over time are critical for clinical interpretation. Your oncologist will correlate the result with your clinical status.
What does a negative (not detected) result mean?
A negative result means the CBFB-MYH11 fusion transcript was not detected within the sensitivity limits of the assay, suggesting molecular remission. However, a negative result does not guarantee the complete absence of leukemic cells. Continued monitoring as per your physician's schedule is important.
How often should MRD monitoring be performed?
The frequency of MRD monitoring depends on your treatment protocol and physician's recommendation. Generally, MRD is assessed after each cycle of induction and consolidation chemotherapy, and then at regular intervals during follow-up (typically every 1-3 months during the first year). Your treating oncologist will determine the optimal monitoring schedule.
What is the cost of this test at DNA Labs India?
The Inv16 (p13q22) / t(16;16)(p13q22) Gene Rearrangement Quantitative MRD Monitor Test is available at DNA Labs India for INR ?7500. This price includes free home sample collection in major cities across India.
How long does it take to receive the test results?
Results are typically available within 2-3 business days. Samples submitted on Monday by 11:00 AM will have reports by Wednesday. Samples submitted on Thursday by 11:00 AM will have reports by Saturday. Digital reports are shared via Online Portal, Email, and WhatsApp.
Is home sample collection available for this test?
Yes, DNA Labs India offers complimentary home sample collection for this test across major cities in India including Mumbai, Delhi, Bangalore, Hyderabad, Chennai, Kolkata, Pune, Ahmedabad, and many more. You can book online to schedule a home collection.
Can this test be used for the initial diagnosis of AML?
While this test can detect the CBFB-MYH11 fusion transcript at diagnosis, it is primarily designed as a quantitative MRD monitoring tool. Initial diagnosis of AML typically involves a combination of bone marrow morphology, immunophenotyping by flow cytometry, conventional cytogenetics, and fluorescence in situ hybridization (FISH). Your hematologist will recommend the appropriate panel of tests at diagnosis.
What is the significance of inv(16) and t(16;16) in AML prognosis?
Both inv(16)(p13q22) and t(16;16)(p13q22) result in the CBFB-MYH11 fusion gene and are classified as core-binding factor (CBF) AML abnormalities. Per ELN (European LeukemiaNet) guidelines, these rearrangements are associated with a favorable prognosis when treated with intensive chemotherapy including high-dose cytarabine. However, the presence of additional mutations such as KIT may modify the risk assessment.
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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