Oncomine Tumour Mutation Burden [TMB] Test
About Oncomine Tumour Mutation Burden [TMB] Test
| Field | Value |
|---|---|
| Also Known As | TMB Test, Tumour Mutational Load (TML) Test, Tumour Mutation Burden Test, Oncomine TML Assay |
| Sample Type | FFPE block (formalin-fixed, paraffin-embedded) |
| Fasting Required | No |
| Report Time | 30 days |
| Recommended For | Adults and children with solid tumours being considered for immunotherapy |
| Price | Starting at ₹38,400 |
What Is an Oncomine Tumour Mutation Burden [TMB] Test?
The Oncomine tumour mutation burden [TMB] test is a specialised genetic test that measures the total number of mutations found in the DNA of tumour cells. It uses next-generation sequencing (NGS), a technology that reads the genetic code of the tumour in detail. The test is ordered by oncologists for patients with advanced solid tumours who are being evaluated for immunotherapy treatment. It is also known as the TMB test, tumour mutational load (TML) test, tumour mutation burden test, or Oncomine TML assay.
What Does an Oncomine Tumour Mutation Burden [TMB] Test Measure?
This test analyses tumour DNA to count the number of somatic mutations, meaning genetic changes that have occurred in the tumour cells and are not inherited. Results are reported as the number of mutations per megabase (mut/Mb) of DNA sequenced. The key parameters measured are listed below:
| Parameter | What It Represents |
|---|---|
| TMB Score | Total count of somatic mutations per megabase of tumour DNA sequenced |
| Mutation Count | Includes single nucleotide variants (changes in one DNA letter) and small insertions or deletions in tumour genes |
Why Is an Oncomine Tumour Mutation Burden [TMB] Test Done?
This test is not used to diagnose cancer. It is ordered after a cancer diagnosis has been made to help oncologists decide whether a patient may benefit from a type of treatment called immune checkpoint inhibitor therapy.
Common Symptoms That May Require This Test
This test is not triggered by symptoms in the usual sense. Your oncologist may order it in the following clinical situations:
- Newly diagnosed advanced or metastatic solid tumour requiring treatment planning
- Cancer that has not responded well to standard chemotherapy or targeted therapy
- A tumour type known to benefit from immune checkpoint inhibitor drugs
- Recurrence of a previously treated cancer where immunotherapy is being reconsidered
- Need to assess multiple biomarkers alongside PD-L1 expression or MSI status
Conditions This Test Can Help Detect
This test does not detect cancer itself. Instead, it guides treatment decisions across several solid tumour types. Cancers where TMB is a relevant biomarker include the following:
- Non-small cell lung cancer (NSCLC)
- Melanoma (skin cancer)
- Colorectal cancer
- Urothelial cancer (bladder and urinary tract)
- Renal cell carcinoma (kidney cancer)
- Gastric (stomach) cancer
- Other advanced solid tumours being evaluated for immune checkpoint inhibitor therapy
How to Prepare and What to Expect
The Oncomine tumour mutation burden [TMB] test procedure does not require any special preparation on your part in most cases. Your oncologist and the diagnostic team will guide you through the steps.
Do You Need to Fast?
No fasting is required for this test. The sample is tumour tissue, not blood or urine, so food and drink do not affect collection. Always follow the specific instructions provided by your doctor or laboratory.
Practical Tips Before Your Test
Keep the following points in mind before proceeding with the test:
- Bring a detailed clinical history including your symptoms, previous test results, and relevant medical records, as this is required for the test
- Discuss with your oncologist whether archived tissue from a past biopsy or surgery can be used, which may avoid the need for a new procedure
- If fresh tissue is needed, your doctor will arrange a biopsy; archival FFPE blocks collected within approximately three months are often acceptable
- Ensure your oncologist is aware of all current medications, as some treatments may affect tumour tissue quality
Step-by-Step Procedure
The Oncomine tumour mutation burden [TMB] test procedure involves several stages from tissue collection to result generation. Here is what to expect:
- Your oncologist determines that an FFPE tumour tissue block is needed. This may come from archived tissue stored from a previous biopsy or surgery, or a new biopsy may be arranged.
- If a new biopsy is required, a trained specialist collects tumour tissue using a needle biopsy (a hollow needle extracts a small tissue core) or a surgical incision biopsy (a small cut to remove part of the tissue).
- The collected tissue is preserved using formalin and then embedded in paraffin wax, creating the FFPE block. This preserves the tissue for transport and analysis.
- The block is sent to the laboratory, where DNA is extracted from the tumour tissue.
- The extracted DNA undergoes targeted next-generation sequencing (NGS) using the Oncomine assay, which sequences a defined portion of the tumour genome to quantify mutations accurately.
- The sequencing data is analysed by a specialist, the TMB score is calculated, and a report is generated for your oncologist to review with you.
Factors That Can Affect Accuracy
Certain sample and technical factors can influence the reliability of results. These include the following:
- Poor DNA quality resulting from improper formalin fixation during tissue preservation
- Low tumour purity, meaning the sample contains too few cancer cells relative to normal tissue
- Deamination artefacts, which are false mutations sometimes introduced during sample processing
- Tumour heterogeneity, where different areas of the tumour carry different mutations
- Technical variables including panel size, sequencing platform, and the bioinformatics pipeline used to analyse results
Understanding Your Oncomine Tumour Mutation Burden [TMB] Test Results
Your oncologist will explain your results in full, taking into account your cancer type, stage, and overall health. The table below shows how TMB results are generally classified:
| Classification | TMB Score | What It May Indicate |
|---|---|---|
| TMB-Low | Less than 10 mutations per Mb | Tumours carry fewer somatic mutations; less likely to respond to immunotherapy based on TMB alone |
| TMB-High | 10 or more mutations per Mb | Tumours carry a higher mutation load; may be more likely to respond to immune checkpoint inhibitor therapy |
Disclaimer: 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 factors relating to sample quality can affect result accuracy. Your laboratory will flag these where relevant:
- Formalin fixation can reduce DNA quality and introduce deamination artefacts, false mutations that may artificially inflate the TMB score.
- Low tumour purity (insufficient cancer cells in the sample) can reduce the sensitivity of the assay and may lead to underestimation of the true TMB score.
- Tumour heterogeneity means that mutations vary across different regions of the same tumour, and a single biopsy may not capture the full mutational picture.
How to Maintain Healthy Levels
TMB is a feature of tumour biology and is not influenced by diet or lifestyle choices. The following points offer general guidance for patients navigating this process:
- Discuss your TMB result with your oncologist alongside other biomarkers such as PD-L1 expression and microsatellite instability (MSI) status.
- Ask your doctor about the full range of treatment options, as TMB is one of several factors used in immunotherapy decisions.
- Keep copies of your previous biopsy reports and pathology records, as these may be needed for further testing or second opinions.
Lupin Diagnostics Oncomine Tumour Mutation Burden [TMB] Test Price
The Oncomine tumour mutation burden [TMB] test cost at Lupin Diagnostics starts at ₹38,400. This test requires a visit to a hospital for a biopsy procedure or the submission of an FFPE tissue block through your treating oncologist to the Lupin Diagnostics centre. Home collection is not available for this test. The table below shows indicative prices:
| City | Approximate Price (₹) |
|---|---|
| Mumbai | 48000 |
| Pune | 48000 |
| Bangalore | 48000 |
| Chennai | 48000 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps for Oncomine tumour mutation burden [TMB] test online booking:
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time, or coordinate with your oncologist to send the FFPE tissue block directly to the nearest Lupin Diagnostics processing centre.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The Oncomine tumour mutation burden [TMB] test is a next-generation sequencing assay that counts the number of genetic mutations in a patient's tumour tissue. The result is expressed as mutations per megabase of DNA. It helps oncologists assess whether a cancer patient is likely to respond to immunotherapy.
This test is recommended for patients with advanced or metastatic solid tumours who are being considered for immune checkpoint inhibitor treatment. Your oncologist will advise whether it is appropriate based on your cancer type, stage, and treatment plan.
Yes, in many cases archived FFPE tissue blocks from a past biopsy or surgery can be submitted for this test, avoiding the need for a new procedure. Your oncologist will confirm whether your existing sample is suitable and meets the laboratory's quality requirements.
A TMB-high result (10 or more mutations per megabase) indicates that the tumour carries a relatively large number of somatic mutations. This may suggest the cancer is more likely to respond to certain immunotherapy medicines. Your oncologist will explain what this means for your specific treatment plan.
No. A TMB-low result does not automatically rule out immunotherapy. Treatment eligibility depends on several factors, including PD-L1 expression, microsatellite instability status, cancer type, and your overall clinical picture. Your oncologist will consider all relevant information before making a recommendation.
The report turnaround time at Lupin Diagnostics is 30 days from the time the sample is received and accepted by the laboratory. The test results are delivered directly via email or WhatsApp.
No, the Oncomine tumour mutation burden [TMB] test home collection is not available. Tumour tissue must be collected in a clinical setting through biopsy or surgery. The FFPE block is then submitted to a Lupin Diagnostics centre for NGS analysis.
Oncomine Tumour Mutation Burden [TMB] Test
