Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR
About Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR
| Field | Value |
|---|---|
| Also Known As | Oncomine Comprehensive Panel + TMB + MSI Test, Comprehensive Genomic Profiling (CGP) Panel, Oncomine CGP Plus |
| Sample Type | FFPE tumor tissue block and peripheral blood (EDTA) |
| Fasting Required | No fasting required |
| Report Time | 30 days |
| Recommended For | Adults and children with solid tumors requiring genomic profiling for treatment selection |
| Price | Starting at ₹84,000 |
What Is an Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR?
The Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR is an advanced genomic profiling test that analyses tumor tissue using next-generation sequencing (NGS). It examines hundreds of genes in a single test to identify mutations that may be driving a patient's cancer.
Also known as the Oncomine Comprehensive Panel + TMB + MSI test, this test is typically ordered by oncologists when standard treatment options have not worked or when personalised therapy options are being considered. Two samples are required: a formalin-fixed paraffin-embedded (FFPE) tumor tissue block and a peripheral blood sample.
What Does an Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR Measure?
This test analyses a wide range of genomic changes across 517 genes simultaneously. The following alterations and biomarkers are assessed:
| Component | What It Looks For |
|---|---|
| Single Nucleotide Variants (SNVs) | Single-letter DNA changes that may activate cancer growth |
| Insertions and Deletions (Indels) | Small additions or removals within gene sequences |
| Copy Number Variations (CNVs) | Extra or missing copies of specific genes |
| Gene Fusions | Abnormal joining of two genes that can produce cancer-driving proteins |
| Tumor Mutational Burden (TMB) | Total number of mutations per megabase of DNA; helps predict immunotherapy response |
| Microsatellite Instability (MSI) | Faulty DNA repair markers; detected by PCR analysis |
| Homologous Recombination Deficiency (HRD) | Reduced ability of cells to repair DNA breaks; relevant to targeted therapy selection |
Why Is an Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR Done?
This test is ordered when a doctor needs a detailed genetic picture of a patient's tumor to guide treatment decisions. The following situations may prompt the test.
Common Symptoms That May Require This Test
A doctor may recommend this test when a patient presents with the following symptoms, particularly in the context of a known or suspected cancer diagnosis:
- Unexplained and persistent weight loss
- Ongoing fatigue with no clear cause
- An unusual lump or mass that has been identified
- Abnormal bleeding not related to injury
- Chronic pain that does not resolve
- Changes in the appearance of skin lesions
- Difficulty swallowing or breathing
Conditions This Test Can Help Detect
The Oncomine Comprehensive Panel + TMB + MSI test is used in the assessment and management of the following conditions:
- Advanced solid tumors, including lung, colorectal, breast, ovarian, gastric, pancreatic, and melanoma
- Cancers of unknown primary (CUP), where genomic data may help identify the tumor's origin
- Refractory or relapsed cancers where standard therapies have not produced a response
- Tumors with mismatch repair (MMR) deficiencies associated with Lynch syndrome
How to Prepare and What to Expect
Because this test uses tumor tissue rather than a routine blood draw, preparation involves your treating doctor and the hospital or surgical team. The following guidance applies.
Do You Need to Fast?
No fasting is required for this test. The primary sample is tumor tissue obtained through a biopsy or surgical procedure, and fasting rules do not apply.
Practical Tips Before Your Test
Please keep the following points in mind before your sample is submitted for testing:
- Bring a detailed clinical history including your symptoms, previous test results, and family history, as this is required for the test
- Ensure the FFPE tumor block or unstained slides come from a procedure where adequate tissue was collected (at least 20% tumor cell content is typically recommended)
- Inform your oncologist about all previous biopsies, surgeries, or tissue collections, as archival tissue may sometimes be used
- Make sure the specimen is accompanied by the associated pathology report
- A 3 ml peripheral blood sample in an EDTA tube will also be collected alongside the tissue sample
Step-by-Step Procedure
Tumor Tissue (FFPE Block)
- Tumor tissue is obtained through a surgical biopsy or resection performed in a clinical setting by your surgical or oncology team
- The tissue is preserved using a formalin-fixation and paraffin-embedding (FFPE) process, which is the standard method for storing and analysing tumor specimens
- A pathologist reviews the block and selects the most representative tumor sections
- DNA and RNA are extracted from the selected tissue in the laboratory
- Amplicon libraries are prepared using multiplex PCR primers, and next-generation sequencing is performed
- Specialised bioinformatics software analyses the sequencing data, and a detailed genomic report is generated
Peripheral Blood Sample
- A trained phlebotomist cleans the inside of your elbow with an antiseptic
- A small needle is used to draw approximately 3 ml of blood into a lavender-top EDTA tube
- The sample is labelled and stored at 2 to 8°C before being transported to the laboratory
Factors That Can Affect Accuracy
Several pre-analytical and sample-related factors can influence the reliability of results:
- Poor quality of FFPE tissue preservation at the time of fixation
- Insufficient tumor content in the biopsy sample (below the recommended threshold)
- Degraded DNA, especially in older FFPE blocks stored for more than two years
- Deamination artefacts that can arise from formalin fixation
- Improper storage or transport conditions for the sample
Understanding Your Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR Results
Results from this test require careful interpretation by a qualified oncologist or molecular pathologist. The table below summarises key reporting thresholds.
| Parameter | Threshold or Status | Interpretation |
|---|---|---|
| TMB | 10 or more mutations/megabase (mut/Mb) | TMB-High: may predict response to immunotherapy |
| TMB | Below 10 mut/Mb | TMB-Low: standard reference threshold |
| MSI | MSI-H (score of 0.15 or above, or at least two mutant markers) | Microsatellite Instability-High |
| MSI | MSS (Microsatellite Stable) | Normal repair function |
| Gene Variants | Pathogenic or Likely Pathogenic | Clinically actionable alteration identified |
| Gene Variants | Variant of Uncertain Significance (VUS) | Requires clinical correlation |
| HRD | Positive or Negative | Indicates presence or absence of DNA repair deficiency |
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 sample-related conditions can affect how results are reported:
FFPE samples with formalin-induced deamination artefacts may produce false-positive variant calls, requiring careful bioinformatics filtering. Tissue with low tumor cell content (below 20%) may yield unreliable or incomplete results. Older archival FFPE blocks may contain degraded DNA, which can reduce the depth and accuracy of sequencing.
Managing Your Oncomine Results and Follow-Up
The following steps support your overall wellbeing and care:
- Attend all scheduled follow-up appointments with your oncologist to track your treatment response
- Discuss genetic counselling with your doctor if the results suggest a hereditary cancer syndrome such as Lynch syndrome
- Maintain a balanced diet and regular physical activity as advised by your healthcare team to support your wellbeing during treatment
Lupin Diagnostics Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR Price
The Oncomine Comprehensive Panel + TMB + MSI test price starts at ₹84,000 at Lupin Diagnostics. This is a super specialised oncology test that requires surgically obtained tumor tissue and must be processed at an accredited laboratory; home collection is not available. The table below shows indicative city prices:
| City | Approximate Price (₹) |
|---|---|
| Mumbai | 84,000 |
| Delhi | 84,000 |
| Bengaluru | 84,000 |
| Chennai | 84,000 |
| Hyderabad | 84,000 |
| Pune | 84,000 |
| Kolkata | 84,000 |
| Ahmedabad | 84,000 |
Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
The following steps explain how to arrange the Oncomine Comprehensive Panel + TMB + MSI 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 for sample submission; your FFPE tissue block and blood sample will need to be submitted in person
- Receive your report via email or WhatsApp within 30 days of sample receipt
Frequently Asked Questions
The Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR is a next-generation sequencing test that analyses tumor tissue across hundreds of genes in a single run. It detects DNA mutations, gene fusions, copy number changes, TMB, MSI status, and HRD. This gives oncologists a detailed genetic profile of the tumor to guide treatment decisions.
This test is typically recommended for patients with advanced or metastatic solid tumors, including lung, colorectal, breast, and ovarian cancers, among others. It is also useful for patients whose cancer has not responded to initial treatments or where the primary site of cancer is unknown. Your oncologist will advise whether this test is appropriate for your situation.
TMB is a measure of the total number of mutations found in the tumor's DNA, expressed per megabase of sequenced DNA. A higher TMB score (10 or more mutations per megabase) may indicate that the tumor is more likely to respond to immunotherapy. Your oncologist will explain what your specific TMB result means for your treatment options.
MSI-High means the tumor has a faulty DNA repair system, leading to an accumulation of mutations in repetitive DNA regions. MSI-High status is used to screen for Lynch syndrome, assess cancer prognosis, and guide treatment decisions, including eligibility for certain immunotherapy drugs. This result must always be discussed with your oncologist.
At Lupin Diagnostics, the report turnaround time for this test is 30 days from the date the sample is received at the laboratory. This extended timeline reflects the complexity of next-generation sequencing and the detailed bioinformatics analysis involved.
Yes. In addition to the FFPE tumor tissue block, a 3 ml peripheral blood sample collected in a lavender-top EDTA tube is required. This blood sample is used as a germline reference, helping the laboratory distinguish tumor-specific mutations from inherited genetic variants.
In many cases, archival FFPE blocks can be used, provided the tissue was properly preserved and the DNA is of sufficient quality. However, older blocks (typically more than two years old) may have degraded DNA, which can affect the reliability of results. Your oncologist or the laboratory team will assess whether your archived tissue sample is suitable before proceeding.
Oncomine Comprehensive Assay + Oncomine Tumor Mutation Burden (TMB) + MSI by PCR
