FLT3 (AML) ITD, D835 by PCR Test: Booking, Price, and Results
About FLT3 (AML) ITD, D835 by PCR Test: Booking, Price, and Results
| Field | Value |
|---|---|
| Also Known As | FLT3 Mutation Analysis, FLT3-ITD/TKD Mutation Test, FLT3 Gene Mutation Detection, FMS-like Tyrosine Kinase 3 Mutation Test |
| Sample Type | Bone marrow aspirate (preferred) |
| Fasting Required | No fasting required |
| Report Time | 10 days |
| Recommended For | Adults and children diagnosed with or suspected of having acute myeloid leukaemia (AML) |
| Price | Starting at ₹5,400 |
What Is an FLT3 (AML) ITD, D835 by PCR Test?
The FLT3 (AML) ITD, D835 by PCR test is a specialised molecular test that detects specific mutations in the FLT3 gene (FMS-like Tyrosine Kinase 3), which plays a role in normal blood cell development. It is ordered for patients diagnosed with or suspected of having acute myeloid leukaemia (AML). AML is an aggressive blood cancer that causes uncontrolled growth of immature blood cells in the bone marrow. This test uses a technique called 'endpoint PCR' (polymerase chain reaction) to identify two distinct types of FLT3 mutations from a bone marrow sample. It is also referred to as FLT3 Mutation Analysis or the FLT3-ITD/TKD Mutation Test.
What Does an FLT3 (AML) ITD, D835 by PCR Test Measure?
This test looks for two specific types of activating mutations in the FLT3 gene, both of which cause the FLT3 receptor to stay permanently switched on, leading to uncontrolled cell growth. The following components are analysed:
| Parameter | What It Detects |
|---|---|
| FLT3-ITD (Internal Tandem Duplication) | A segment of DNA is duplicated and reinserted within the gene, affecting the juxtamembrane region of the protein |
| FLT3-D835/TKD (Tyrosine Kinase Domain Mutation) | A single amino acid change in the kinase domain of the gene, most commonly at position 835 |
| FLT3-ITD Allelic Ratio | The proportion of mutated FLT3 genes relative to normal FLT3 genes is calculated only when an ITD mutation is detected and used for prognosis |
Why Is an FLT3 (AML) ITD, D835, by PCR Test Done?
This is a specialised oncology test ordered by haematologists and oncologists when AML is diagnosed or suspected, or when monitoring disease in known AML patients.
Common Symptoms That May Require This Test
A doctor may order this test when a patient presents with symptoms consistent with AML. These symptoms include:
- Persistent and unexplained fatigue or weakness
- Frequent infections that do not resolve easily
- Unusual or easy bruising and bleeding
- Shortness of breath without a clear cause
- Unexplained weight loss or loss of appetite
- Bone or back pain without injury
Conditions This Test Can Help Detect
The FLT3 (AML) ITD, D835 by PCR test, assists in the evaluation of several clinical situations:
- Acute myeloid leukaemia (AML) at initial diagnosis
- Risk stratification and prognosis assessment in confirmed AML patients
- Assessment of eligibility for targeted FLT3 inhibitor therapies
- Evaluation of mutation status in patients with relapsed or treatment-resistant AML
FLT3 (AML) ITD, D835 by PCR Test for Chronic Disease Monitoring
In patients with AML, this test is not a one-time investigation. Doctors may repeat the AML test at relapse or when the disease becomes refractory (resistant to treatment) to reassess the mutation status and guide further treatment decisions. FLT3 mutation status can change over the course of the disease, so retesting is an important part of ongoing management. Results at each stage help guide decisions about targeted therapies.
How to Prepare and What to Expect
No special preparation is needed before this test. However, there are a few practical points to keep in mind before your appointment.
Do You Need to Fast?
No fasting is required for the FLT3 (AML) ITD, D835, by PCR test. You may eat and drink normally before your appointment.
Practical Tips Before Your Test
Before arriving at the collection centre, keep the following in mind:
- Bring a detailed clinical history including your symptoms, previous test results and any relevant medical records, as this is required for the test.
- Inform your doctor if you have received a blood transfusion recently, as this can affect test outcomes.
- Tell the laboratory or collecting doctor about all current medications, particularly blood-thinning drugs.
- This test requires a bone marrow aspirate, which is collected at a hospital or clinic. Ensure your appointment is at a facility equipped for this procedure.
Step-by-Step Procedure
Here is what typically happens during sample collection for this test:
- You will be taken to a procedure room. The doctor will explain the process and answer any questions you have.
- The skin over the collection site (usually the hip bone) is cleaned, and a local anaesthetic is applied to numb the area.
- A small needle is used to draw approximately 3 ml of bone marrow aspirate into a sodium heparin (green-top) tube.
- The collection site is covered with a small dressing. You may feel mild soreness for a day or two afterwards.
- The sample is labelled and stored refrigerated at 2 to 8 degrees Celsius to maintain its integrity.
- Endpoint PCR analysis is carried out in the lab to detect the presence of FLT3-ITD and FLT3-D835 mutations.
Factors That Can Affect Accuracy
Certain factors can influence the reliability of the AML test procedure:
- A blast cell (leukaemic cell) count below 30% in the sample may reduce the sensitivity of the test.
- Recent blood transfusions can dilute the leukaemic cell population in the sample.
- Clotted, grossly haemolysed or improperly stored samples may be unsuitable for analysis.
- Bone marrow or blood samples collected after chemotherapy, when blast counts are very low, may not yield reliable results.
- Delays in processing or inadequate refrigeration during transport can compromise DNA quality.
Understanding Your FLT3 (AML) ITD, D835, by PCR Test Results
Results from this test must be reviewed by a qualified haematologist or oncologist alongside your full clinical picture, disease stage, and other genetic findings. Below is a summary of what the reported parameters typically indicate.
| Parameter | Normal Result | Positive (Abnormal) Result |
|---|---|---|
| FLT3-ITD | Not Detected | Detected (size of insertion and allelic ratio reported) Mutation present in the juxtamembrane domain |
| FLT3-D835/TKD | Not Detected | Detected (amino acid change reported) Point mutation in the tyrosine kinase domain |
| FLT3-ITD Allelic Ratio | Not applicable | Low (less than 0.5) or High (0.5 or above); A ratio below 0.5 is generally more favourable; ratio at or above 0.5 is associated with a more difficult prognosis |
A negative result means no FLT3-ITD or FLT3-D835 mutations were found in the sample. This does not rule out AML, as the disease can be driven by other genetic changes that require separate testing.
A positive FLT3-ITD result, particularly with a high allelic ratio, is associated with a greater risk of relapse and shorter remission. A positive FLT3-D835 result also indicates an activating mutation, though its effect on prognosis is considered less clear-cut than FLT3-ITD.
These ranges are general guidelines. Your doctor will interpret your results based on your age, health history and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Certain situations can affect how results are interpreted:
- A low blast count in the sample, often seen after chemotherapy, can lead to a false-negative result, meaning a mutation may be present but go undetected. If your sample was collected during or shortly after treatment, your doctor may recommend retesting.
- Concurrent medical conditions or recent blood transfusions can also alter the cellular composition of the sample, which your doctor will take into account when reviewing results.
How to Maintain Healthy Levels
This test detects genetic mutations in leukaemia cells and is not related to lifestyle factors. There are no dietary or lifestyle changes that prevent these mutations. General wellbeing during AML management can be supported by:
- Staying well hydrated and eating a balanced diet as guided by your care team.
- Reporting any new or changing symptoms to your doctor promptly.
- Attending all follow-up appointments with your haematologist or oncologist as scheduled.
- Informing your doctor promptly if you notice any new or returning symptoms.
- Discussing all treatment options, including targeted therapies, openly with your care team.
Lupin Diagnostics FLT3 (AML) ITD, D835 by PCR Test Price
The AML test cost at Lupin Diagnostics starts at ₹5,400. This test requires a visit to a Lupin Diagnostics centre or an affiliated hospital for bone marrow aspirate collection. Home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 5400 |
| CHENNAI | 5400 |
| HYDERABAD | 5400 |
| KOLKATA | 5400 |
| NAVI MUMBAI | 5400 |
| PUNE | 5400 |
Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Booking your AML test online with Lupin Diagnostics is straightforward:
- Select the FLT3 (AML) ITD, D835 by PCR test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time for bone marrow sample collection.
- Receive your report via email or WhatsApp within 10 days of sample collection.
Frequently Asked Questions
FLT3 is a gene that controls a protein involved in normal blood cell production. Mutations in this gene are found in approximately one-third of AML patients, making it one of the most frequently altered genes in the disease. Detecting these mutations helps doctors assess how the disease is likely to behave and which treatments may be most effective.
FLT3-ITD involves the insertion of a repeated segment of DNA into a specific region of the gene called the juxtamembrane domain. FLT3-D835 is a point mutation, meaning a single building block of DNA is changed in the tyrosine kinase domain. Both mutations cause the FLT3 receptor to remain permanently active, driving uncontrolled cell growth.
Bone marrow aspirate contains a higher concentration of leukaemic cells, which makes mutation detection more sensitive and reliable, particularly in newly diagnosed and relapsed AML. Peripheral blood may be used when bone marrow is not available, provided there are enough leukaemic cells present in the sample.
A positive result means that one or both FLT3 mutations were detected in the sample. This information has prognostic value and also indicates that the patient may be eligible for targeted treatments called FLT3 inhibitors. Your haematologist or oncologist will explain what the finding means for your specific situation.
Yes, retesting may be recommended if the disease relapses or becomes resistant to treatment. FLT3 mutation status can change after therapy, so an updated result helps guide the next steps in treatment planning.
The allelic ratio measures how much of your FLT3 gene is mutated compared to the normal version. A ratio below 0.5 is generally associated with a more favourable outlook, while a ratio at or above 0.5 is linked to a more difficult prognosis. Your doctor will use this alongside other findings to guide your care.
The report for this test is delivered within 10 days of sample collection. Results are made available digitally via email or WhatsApp. Your doctor will discuss the findings with you at your next appointment.
Coverage depends on your individual insurance policy and insurer. It is advisable to check with your insurance provider before booking, as specialised molecular tests may be subject to specific documentation requirements or pre-authorisation.
FLT3 (AML) ITD, D835 by PCR Test: Booking, Price, and Results
