Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test
About Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test
| Field | Value |
|---|---|
| Also Known As | Oncomine Comprehensive Plus Panel, CGP (Comprehensive Genomic Profiling), OCA Plus, 553-Gene Cancer Panel, Multi-Gene NGS Panel with TMB/MSI/PDL1 |
| Sample Type | FFPE tissue block (tumour tissue) and peripheral blood |
| Fasting Required | No |
| Report Time | 30 days |
| Recommended For | Adults of all genders with advanced or metastatic solid tumours |
| Price | Starting at ₹1,62,000 |
What Is an Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test?
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test is an advanced next-generation sequencing (NGS) test for cancer patients. It analyses 553 cancer-associated genes in tumour tissue to detect genetic changes driving cancer growth. The test also measures three key biomarkers: tumour mutational burden (TMB), microsatellite instability (MSI), and PD-L1 expression, to guide personalised treatment decisions. It is also known as the Oncomine Comprehensive Plus Panel, CGP (Comprehensive Genomic Profiling), OCA Plus, 553-Gene Cancer Panel, or Multi-Gene NGS Panel with TMB/MSI/PDL1.
What Does an Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test Measure?
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test detects a wide range of genetic alterations, including single-nucleotide variants (point mutations), insertions and deletions, copy number variations, and gene fusions. The 553 genes tested are grouped by their function in cancer biology. The table below lists each gene category, representative genes, and why they are tested:
| Gene Category | Representative Genes Tested | Purpose of Testing |
|---|---|---|
| Oncogenes (genes that drive cancer growth) | EGFR, KRAS, NRAS, BRAF, PIK3CA, MET, ERBB2, ALK, ROS1, HRAS, ARAF, RAF1, MAP2K1, MAP2K2, MAPK1, GNA11, GNAQ, GNAS, CTNNB1, MYC, MYCN, MYCL, CDK4, CDK6, JAK1, JAK2, JAK3, FGFR1, FGFR2, FGFR3, FGFR4, KIT, PDGFRA, PDGFRB, RET, MDM2, MDM4, AKT1, AKT2, AKT3, MTOR | Identify targetable mutations for targeted therapies such as EGFR inhibitors, MEK inhibitors, and kinase inhibitors |
| Tumour Suppressor Genes (genes that normally prevent cancer) | TP53, RB1, PTEN, APC, BRCA1, BRCA2, NF1, NF2, TP73, CDKN2A, CDKN2B, CDKN1A, CDKN1B, CDKN1C, FAT1, FBXW7, RNF43, LATS1, LATS2, SMAD2, SMAD3, SMAD4, VHL-related genes, AXIN1, AXIN2 | Detect loss of protective function and predict response to specific therapies including PARP inhibitors |
| DNA Repair Genes | BRCA1, BRCA2, ATM, ATR, PALB2, CHEK1, CHEK2, RAD51B, RAD51C, RAD51D, RAD50, RAD52, RAD54L, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, FANCM, MRE11, NBN, BLM, RECQL4, ERCC2, ERCC3, ERCC4, ERCC5, MUTYH | Assess homologous recombination deficiency (HRD) and guide PARP inhibitor and platinum-based therapy selection |
| Cell Cycle Regulators | CDK2, CDK4, CDK6, CDK7, CDK8, CDK12, CCND1, CCND2, CCND3, CCNE1, CDKN2A, CDKN2B, CDKN2C, CDKN1A, CDKN1B, RB1, AURKA, AURKB, AURKC | Identify CDK4/6 inhibitor sensitivity and evaluate proliferation-driving alterations |
| Chromatin Remodelling and Epigenetic Genes | ARID1A, ARID1B, ARID2, ARID5B, KMT2A, KMT2B, KMT2C, KMT2D, EZH2, DNMT1, DNMT3A, DNMT3B, DOT1L, SETD2, SETBP1, CREBBP, EP300, ASXL1, ASXL2, PBRM1, SMARCA4, SMARCB1, CHD2, CHD4, CHD8 | Understand epigenetic dysregulation and predict potential immunotherapy response |
| Receptor Tyrosine Kinases | FGFR1, FGFR2, FGFR3, FGFR4, KIT, PDGFRA, PDGFRB, RET, NTRK1, NTRK2, NTRK3, KDR, IGF1R, EGFR, ERBB2, ERBB3, ERBB4, DDR1, DDR2, MET, HGF, CSF1R, LTK | Detect fusion genes and mutations actionable with targeted kinase inhibitor therapies |
| PI3K/AKT/mTOR Pathway Genes | PIK3CA, PIK3CB, PIK3CD, PIK3R1, PIK3R2, AKT1, AKT2, AKT3, MTOR, PTEN, RPTOR, RICTOR, RPS6KB1, RPS6KB2, RPS6KA4, RHEB | Assess pathway activation and suitability for PI3K, AKT, and mTOR inhibitor therapies |
| Immune Checkpoint and Antigen Presentation Genes | CD274 (PD-L1), PDCD1LG2 (PD-L2), B2M, HLA-A, HLA-B, HLA-C, JAK1, JAK2, CTLA4, IDO1, IDO2, IFNGR1, IFNGR2, IRF1, NLRC5, TAP1, TAP2, TAPBP, RFX5, RFXAP | Predict immunotherapy response and identify immune evasion mechanisms |
| Mismatch Repair (MMR) Genes | MLH1, MSH2, MSH3, MSH6, PMS1, PMS2 | Detect microsatellite instability (MSI-H) to guide immunotherapy decisions |
| Genomic Signatures | TMB (Tumour Mutational Burden), MSI (Microsatellite Instability), HRD (Homologous Recombination Deficiency) | Pan-cancer biomarkers for immunotherapy eligibility and treatment selection |
| Additional Cancer-Associated Genes | ABL1, ABL2, ABR, ABRAXAS1, ACVR1, ACVR1B, ACVR2A, ADGRA2, AJUBA, AKAP9, ALOX12B, ALOX15B, AMER1, ANKRD11, ANKRD26, APLNR, ARFRP1, ARHGAP26, ARHGAP35, ASXL1, ASXL2, AXIN1, AXIN2, BAP1, BARD1, BCL2, BCOR, BIRC3, BTG1, BTG2, BTK, CARD11, CASP8, CASR, CBFB, CBL, CBLB, CDC73, CDH1, CENPA, CFTR, CIC, CIITA, CKS1B, COL17A1, CPA1, CRBN, CRKL, CRLF2, CSAD, CSNK1A1, CTCF, CUL3, CUL4A, CUL4B, CUX1, CYLD, DAXX, DCUN1D1, DDX3X, DDX5, DEFB134, DHX9, DICER1, DIS3, DIS3L2, DLX1, DNAJB1, DPYD, E2F3, EED, EGFL7, EIF4A2, ELF3, ELOC, EPHA2, EPHA3, ERG, ESR1, ETV1, ETV4, ETV5, ETV6, FAS, FGF19, FLT1, FOXA1, FOXA2, FOXL2, FOXO1, FOXP1, FUBP1, GATA3, GATA6, GNA13, GPS2, H3F3B, HIF1A, HIST1H1C, HIST1H3B, HIST1H3C, HIST1H3D, HIST1H3E, HIST1H3F, HIST1H3G, HIST1H3H, HIST1H3I, HIST1H3J, HIST2H3C, HNF1A, IDH1, IDH2, IL6ST, JUN, KDM5C, KDM6A, KEAP1, KLF4, LAMP1, LMO1, LRP1B, LYN, LZTR1, MAP2K4, MAP3K1, MAX, MCL1, MECOM, MED12, MEN1, MGA, MGMT, MYB, MYH9, NAB2, NCOA2, NCOR1, NFE2L2, NFKB2, NFKBIA, NKX2, NKX3, NOTCH1, NOTCH2, NOTCH3, NOTCH4, NPM1, NRG1, NSD1, NSD3, NUP93, NUTM1, P2RY8, PAK1, PAK3, PAK7, PARP1, PAX5, PCBP1, PHF6, PIAS3, PIAS4, PIM1, PLCG1, POLE, POLQ, PPM1D, PPP2R1A, PPP2R2A, PPP4R2, PPP6C, PRKAR1A, PSIP1, PSMA1, PSMB5, PSMD1, PSMG2, PTCH1, PTK2, PTPN11, PTPRD, PTPRO, PTPRS, PTPRT, QKI, QSER1, RAC1, RAD21, RASA1, RBM10, REL, REST, RPL22, RPL5, RRM1, RSPO2, RUNX1, SERPINB3, SERPINB4, SF3B1, SLC34A2, SMC1A, SMC3, SMG1, SMO, SOCS1, SOS1, SOX17, SOX9, SPEN, SPOP, SRC, SRSF2, STAG1, STAG2AXL, STAT1, STAT3, STAT5B, STK11, SYK, TAF1, TAF3, TBL1XR1, TBX3, TCF12, TCF7L2, TERT, TET2, TGFBR2, TGFBRN, TMPRSS2, TP53BP1 | Broad coverage of additional driver and passenger mutations relevant across solid tumour types |
Why Is an Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test Done?
This test is ordered by oncologists when a patient requires detailed genetic information about their tumour to guide treatment decisions. It is particularly valuable for advanced or metastatic cancers where standard treatments are insufficient.
Common Symptoms That May Require This Test
The following clinical situations typically prompt an oncologist to recommend this test:
- Advanced or metastatic cancer that has spread to other organs
- Cancer that has not responded adequately to standard chemotherapy
- Cancer recurrence after previous treatment
- Need to identify eligibility for targeted therapy or immunotherapy
- Unexplained or rapid tumour progression
- Cancer of unknown primary origin
- Strong family history suggesting hereditary cancer syndromes
Conditions This Test Can Help Detect
This panel is applicable across a wide range of solid tumour types. Conditions it can help guide treatment for include:
- Non-small cell lung cancer (NSCLC)
- Colorectal cancer
- Breast cancer, including triple-negative breast cancer
- Ovarian cancer
- Gastric and gastrointestinal cancers
- Melanoma
- Prostate cancer
- Pancreatic cancer
- Cholangiocarcinoma (bile duct cancer)
- Childhood neuroblastoma
- Cancers of unknown primary origin
- Any advanced solid tumour requiring precision oncology guidance
How to Prepare and What to Expect
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test procedure involves tumour tissue collection rather than a routine blood draw, so preparation is different from standard laboratory tests.
Do You Need to Fast?
No fasting is required. You can eat and drink normally before the test. However, always follow any specific instructions provided by your doctor.
Practical Tips Before Your Test
Here are some practical steps to prepare for sample submission:
- Bring a detailed clinical history, including your symptoms, previous test results, and family history, as this is required for the test
- Confirm with your oncologist that adequate tumour tissue is available from a recent biopsy or surgical specimen
- Bring prior pathology reports and block location details to the laboratory
- Discuss any previous chemotherapy or radiation with your oncologist, as these may affect the tumour's mutational profile
Step-by-Step Procedure
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test procedure involves two sample types:
FFPE Tissue Block Collection:
- Your oncologist reviews your cancer type, stage, and treatment history and recommends comprehensive genomic profiling.
- A pathologist examines existing tumour tissue (from a prior biopsy or surgery) to confirm that adequate tumour content is present and marks the relevant areas for DNA extraction.
- The laboratory extracts DNA and RNA from the FFPE tissue block under controlled conditions.
- The extracted material is processed using next-generation sequencing (NGS) to analyse all 553 genes.
Peripheral Blood Collection:
- A trained phlebotomist collects 3 ml of blood from a vein in your arm into a lavender-top EDTA tube. The process takes a few minutes and causes minimal discomfort.
- Both the tissue block and blood samples are stored at 2 to 8°C and dispatched to the laboratory for processing.
- Bioinformatics analysis generates a full genomic report. A molecular tumour board reviews findings before the report is shared with your treating oncologist.
Factors That Can Affect Accuracy
Several factors may influence the reliability of test results:
- Low tumour cell content in the FFPE block
- Older FFPE blocks where DNA quality has degraded over time
- Poor tissue fixation quality or prolonged fixation duration
- Decalcified bone specimens, which may yield lower-quality DNA
- Prior chemotherapy or radiation altering the tumour's mutational profile
- Tumour heterogeneity, where different parts of the same tumour carry different mutations
Understanding Your Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test Results
Results from this test cover multiple parameters. Each is interpreted in the clinical context of your cancer type, stage, and treatment history. The table below outlines how key result categories are classified:
| Parameter | Interpretation |
|---|---|
| TMB (Tumour Mutational Burden) | Low (<10 mutations/Mb): Lower likelihood of immunotherapy response. High (≥10 mutations/Mb): Increased likelihood of benefit from immune checkpoint inhibitors. |
| MSI (Microsatellite Instability) | MSS: Stable DNA repair. MSI-L: Low instability; limited clinical significance. MSI-H: Higher likelihood of immunotherapy response; may suggest Lynch syndrome. |
| PD-L1 Expression | Negative: Lower likelihood of immunotherapy response. Low: Potential benefit. High: Greater likelihood of immunotherapy response. |
| Gene Variants | Pathogenic/Likely Pathogenic: Clinically relevant and may guide targeted therapy. VUS: Uncertain significance. Benign: Not clinically relevant. |
| Copy Number Variations | Amplified: Increased gene copies that may drive cancer growth. Deleted: Loss of gene copies that may affect tumour behaviour. Normal: No significant copy number change detected. |
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 conditions can affect how results are read or generated:
- Older FFPE tissue blocks and samples with a low proportion of tumour cells are associated with reduced test reliability; your oncologist may request a fresh biopsy if results are inconclusive.
- Tumour heterogeneity, where different regions of a tumour carry different mutations, can cause sampling bias, meaning results from one tissue sample may not capture all alterations present in the tumour.
How to Maintain Healthy Levels
This test does not measure levels that can be improved through diet or lifestyle changes, as it is a cancer diagnostic test. The following general steps support your care journey:
- Follow your oncologist's recommendations closely based on test findings
- Attend all scheduled follow-up appointments and discuss treatment options openly with your care team
- Maintain overall physical and nutritional health as guided by your doctor during cancer treatment
Lupin Diagnostics Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test Price
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test cost starts at ₹1,62,000 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre or hospital; home collection is not available for this test, as it involves specialised tumour tissue samples. The table below shows indicative prices:
| City | Approximate Price (₹) |
|---|---|
| Mumbai | 162000 |
| Pune | 162000 |
| Bangalore | 162000 |
| Chennai | 162000 |
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 the Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 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, bringing your FFPE tissue block, clinical history, and prior pathology reports.
- Receive your report via email or WhatsApp within 30 days of sample receipt.
Frequently Asked Questions
The Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test is an advanced NGS-based cancer test. It analyses 553 cancer-related genes in tumour tissue, alongside TMB, MSI, and PD-L1 biomarkers, to help oncologists identify the most effective personalised treatment for your cancer.
This test is recommended for patients with advanced or metastatic solid tumours, such as lung cancer, colorectal cancer, breast cancer, or melanoma, particularly when standard treatments have limited effectiveness or when targeted therapy or immunotherapy options need to be identified.
Two samples are required: an FFPE tissue block (from a previous biopsy or surgical procedure) and 3 ml of peripheral blood collected in an EDTA tube. The FFPE block should ideally be less than three years old to ensure adequate DNA quality.
At Lupin Diagnostics, the turnaround time for this test is 30 days from the date of sample receipt. The report is delivered directly via email or WhatsApp.
TMB stands for tumour mutational burden. It measures the total number of mutations present in a tumour's DNA. A high TMB (10 or more mutations per megabase) indicates that the tumour may respond better to immune checkpoint inhibitor therapies, which are a type of immunotherapy.
MSI-high (microsatellite instability-high) means the tumour has a defect in its DNA mismatch repair system. Patients whose tumours are MSI-high may benefit from immune checkpoint inhibitor treatments and may also have a hereditary cancer syndrome called Lynch syndrome, which has implications for family members.
In most cases, an existing FFPE tissue block from a prior biopsy or surgery can be used for the Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 test. Your oncologist and the laboratory pathologist will assess whether the block contains adequate tumour material before testing begins.
Oncomine Comprehensive Plus Panel – 553 Genes + TMB + MSI + PDL1 Test
