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**Overview**: OncoPro TSO500 PDL1 Panel**Introduction**: The OncoPro TSO500 PDL1 Panel is a diagnostic tool designed for comprehensive genomic profiling using FFPE tissue. In India, advanced cancers benefit from broad NGS (TSO500 covers 500+ genes) plus PD-L1 (Dako) for immunotherapy eligibility in NSCLC, urothelial, and other tumors. High morbidity from under-testing in rural/low-SES advanced cancer patients, limited NGS labs, delayed matched therapy or pembrolizumab leading to progression. Per oncology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs NGS for TSO500 genomic profile and IHC for PD-L1 (Dako) expression over 1-2 days (NGS analysis longer) with high accuracy, valuable for tumor mutational burden (TMB), microsatellite instability (MSI), and driver detection. This diagnostic falls under cancer screening and targets patients with advanced solid tumors, addressing accurate detection to guide precision therapy or clinical trials. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling comprehensive profiling and improving outcomes. Its FFPE-based approach ensures reliable multi-omic assessment.**Other Names**: TSO500 Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/oncology, compliant with 2025 standards.**Historical Milestone**: TSO500 + PD-L1 standard in precision oncology; in India, expanding in tertiary centers.**Purpose**: The test assesses 2 parameters including TSO500 genomic profile to guide comprehensive cancer screening, detect alterations/TMB/MSI/PD-L1, inform therapy.**Test Parameters**: 1. TSO500 Genomic Profile, 2. PDL1 (Dako) Expression.**Pretest Condition**: No fasting required; patients should have tumor biopsy.**Specimen**: Formalin-fixed paraffin-embedded block (0.5â€"2 cm³), transported within specified times to maintain sample integrity.Sample Stability: Indefinite when properly stored in formalin/paraffin; testing possible long-term.**Medical History**: Patients should provide details on tumor type, stage, prior therapy.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected alterations including wrong therapy, benefits of profiling, and no additional discomfort (uses existing block).**Procedural Considerations**: The test involves sample processing using NGS/IHC by trained personnel to ensure accurate analysis and interpret results within days/weeks using provided controls. Laboratories must maintain a controlled environment, adhere to quality assurance protocols.**Factors Affecting Result Accuracy**: Poor block quality, inadequate tumor content, or sequencing artifacts can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: High TMB/MSI or PD-L1 high indicates immunotherapy eligibility; drivers indicate TKIs, necessitating specialist input.**Specialist Consultation**: Medical oncologists should be consulted for management.**Additional Supporting Tests**: Tumor board review, liquid biopsy for confirmation.**Test Limitations**: Costly/time-intensive; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Cancer Studies India 2023. |
