Oncomine Tumor Mutation Burden (TMB)
About Oncomine Tumor Mutation Burden (TMB) Test
| Field | Value |
|---|---|
| Also Known As | TMB Test, Tumor Mutational Burden Test, Tumor Mutational Load (TML) Assay, Oncomine TML Assay |
| Sample Type | Tumour tissue (FFPE block: formalin-fixed paraffin-embedded) |
| Fasting Required | No |
| Report Time | 30 Days |
| Recommended For | Adults and children with advanced or metastatic solid tumours being considered for immunotherapy |
| Price | Starting at ₹38,400 |
What Is an Oncomine Tumor Mutation Burden (TMB) Test?
The Oncomine Tumor Mutation Burden (TMB) test is a specialised molecular test that measures how many genetic mutations are present in the DNA of tumour cells. It is ordered after a cancer diagnosis to help oncologists decide whether a patient may benefit from a class of cancer treatment called immune checkpoint inhibitor therapy.
The test uses next-generation sequencing (NGS) technology, which reads large stretches of the tumour's DNA in great detail. It is also referred to as the TMB test or the Tumor Mutational Load (TML) Assay.
What Does an Oncomine Tumor Mutation Burden (TMB) Test Measure?
The Oncomine TMB test analyses tumour tissue DNA across a targeted panel of genes with known cancer associations. The table below summarises what the test evaluates.
| Component | What It Means |
|---|---|
| Tumour Mutational Burden (TMB) | The total count of somatic (acquired) mutations found per megabase of DNA in the tumour |
| Somatic mutations | Genetic changes in tumour cells that were not inherited, including single-letter DNA changes, insertions, and deletions |
| Genetic alterations | Structural changes in the tumour genome identified through deep sequencing of cancer-associated genes |
The result is expressed as the number of mutations per megabase (mut/Mb) of DNA sequenced.
Why Is an Oncomine Tumor Mutation Burden (TMB) Test Done?
The Oncomine TMB test is not ordered based on symptoms. It is prescribed after a confirmed cancer diagnosis to guide treatment planning, specifically to assess whether immunotherapy is likely to work.
Common Situations That May Require This Test
Oncologists typically request this test in the following situations:
- Newly diagnosed advanced or metastatic solid tumour requiring a treatment decision
- Evaluating eligibility for immune checkpoint inhibitor therapy
- Prior treatments have stopped working and alternative options are being considered
- Cancer type known to have variable immunotherapy response rates
- Molecular profiling requested as part of a broader tumour biomarker panel
- Seeking FDA-approved immunotherapy options for a specific tumour type
Conditions This Test Can Help Detect or Guide
The TMB test is used to inform treatment for a range of solid tumours. High TMB levels have been observed in the following cancer types, among others:
- Melanoma and lung cancers (particularly in patients with tobacco or UV exposure history)
- Endometrial, bladder, and oesophageal cancers
- Cervical, anal, and biliary tract cancers
- Small cell lung cancer, thyroid cancer, and neuroendocrine tumours
- Salivary gland, vulvar, and mesothelioma cancers
How to Prepare and What to Expect
The Oncomine Tumor Mutation Burden (TMB) test requires tumour tissue rather than a standard blood draw. No special preparation is needed from the patient, but the tissue sample must meet specific quality standards.
Do You Need to Fast?
No fasting is required for this test. The sample is tumour tissue, not blood or urine.
Practical Tips Before Your Test
Keep the following in mind before submitting a sample for the TMB test:
- Bring a detailed clinical history including your symptoms, previous test results, and any prior cancer treatments, as this is required for the test
- Also carry your histopathology report and any prior immunohistochemistry (IHC) reports if available
- Ensure the tumour tissue block is no more than 60 days old from the date of sectioning
- The sample must contain at least 20% tumour cells to be eligible for testing
- Note that bone samples, including soft tissue tumour masses arising from bone, cannot be accepted
- Inform your oncologist of all medications you are currently taking
Step-by-Step Procedure
Here is what typically happens from tissue collection to report delivery:
- Your doctor arranges a biopsy or uses tissue from a prior surgical procedure to obtain a tumour sample
- The tissue is fixed in formalin and embedded in paraffin wax to create an FFPE block, which preserves the sample for molecular analysis
- The FFPE block is submitted to the laboratory at ambient temperature (18 to 28 degrees Celsius) along with your clinical history
- In the lab, DNA is extracted from the tumour tissue and prepared for sequencing using a targeted NGS panel covering cancer-associated genes
- The sequencing instrument analyses the DNA and counts the number of somatic mutations across the sequenced region
- A specialist reviews the data and generates a report, which is delivered within 30 days
Factors That Can Affect Accuracy
Certain factors can influence the reliability of Oncomine TMB test results:
- Poor tissue fixation or an aged FFPE block may degrade DNA quality
- Tumour cell content below the minimum 20% threshold
- Low DNA yield from the tissue sample
- Insufficient sequencing depth or coverage during the NGS run
- Presence of cytosine deamination artefacts, a chemical change common in older FFPE specimens
Understanding Your Oncomine Tumor Mutation Burden (TMB) Test Results
Results from the Oncomine TMB test are reported as mutations per megabase of DNA. The table below shows general interpretation categories. Your oncologist will review the result in the context of your specific cancer type, overall health, and other biomarker findings.
| TMB Category | Result (mut/Mb) | Interpretation |
|---|---|---|
| TMB-Low | Less than 5 | Less likely to respond to immune checkpoint inhibitor therapy |
| TMB-Intermediate | 5 to 10 | Response may vary; further clinical assessment advised |
| TMB-High | more than 10 | Associated with better outcomes on immune checkpoint inhibitor therapy |
The FDA has approved pembrolizumab for patients with TMB-High solid tumours at a threshold of 10 or more mutations per megabase. Cut-off values, however, may differ between cancer types and between laboratories.
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 biological factors can influence TMB scores:
- Cancers linked to chronic mutagen exposure, such as lung cancer (tobacco) and melanoma (UV radiation), tend to show the highest TMB values.
- Tumours with defective DNA mismatch repair (dMMR) often show both high microsatellite instability (MSI-H) and high TMB simultaneously.
- Tumours carrying POLE or POLD1 gene mutations may show an unusually high number of mutations, a pattern called hypermutation.
How to Maintain Healthy Levels
TMB reflects the genetic characteristics of a tumour and cannot be changed by lifestyle choices. However, the following general points are worth keeping in mind:
- Follow your oncologist's recommended schedule for cancer screening and follow-up.
- Keep all your biomarker reports organised so your care team has a complete picture at each consultation.
- Discuss all test results, including TMB, PD-L1 expression, and MSI status, with your oncologist before any treatment decision is made.
Lupin Diagnostics Oncomine Tumor Mutation Burden (TMB) Price
The Oncomine Tumor Mutation Burden (TMB) test is priced starting at ₹38,400 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre or the submission of a tumour tissue block through your treating hospital. Home collection is not available for this test.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 38400 |
| CHENNAI | 38400 |
| HYDERABAD | 38400 |
| KOLKATA | 38400 |
| NAVI MUMBAI | 38400 |
| PUNE | 38400 |
Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps to book the Oncomine TMB test at Lupin Diagnostics:
- Select the test on the Lupin Diagnostics website
- Choose your city and preferred centre location
- Visit the centre at your scheduled time for sample submission, or arrange for your treating hospital to send the FFPE tissue block directly
- Receive your report via email or WhatsApp within 30 days
Frequently Asked Questions
The Oncomine TMB test is used to measure the number of genetic mutations present in tumour cells. Oncologists use this result to assess whether a cancer patient is likely to respond to immune checkpoint inhibitor therapy. It is one of several biomarkers evaluated when planning cancer treatment.
This test requires a formalin-fixed paraffin-embedded (FFPE) tumour tissue block, obtained through a biopsy or surgical procedure. A standard blood sample is not sufficient. The tissue must contain at least 20% tumour cells and ideally should be no older than 60 days from the date of sectioning.
At Lupin Diagnostics, the report for the Oncomine TMB test is delivered within 30 days. This accounts for DNA extraction, library preparation, next-generation sequencing, and specialist review of the data.
A TMB-High result (generally 10 or more mutations per megabase) suggests the tumour may respond well to immune checkpoint inhibitor therapy. The FDA has approved the drug pembrolizumab specifically for patients with TMB-High solid tumours. Your oncologist will decide on treatment based on this result alongside other clinical factors.
No. The TMB test online booking process begins on the Lupin Diagnostics website, but the test itself requires tumour tissue obtained through a medical procedure. Sample collection and processing must take place in a specialised molecular pathology laboratory. Home collection is not available.
No. TMB is typically assessed alongside other biomarkers such as PD-L1 expression levels and microsatellite instability (MSI) status. Together, these markers give oncologists a fuller picture of how the tumour is likely to behave and which treatments are most appropriate.
Several factors can affect the TMB test procedure outcome, including the quality and age of the FFPE tissue block, the percentage of tumour cells in the sample, and the amount of DNA that can be extracted. Poor tissue fixation or a sample that is too old may lead to DNA degradation, which can affect the reliability of the result. Your care team will advise if the sample needs to be recollected.
Oncomine Tumor Mutation Burden (TMB)
