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**Overview**: Lung Cancer 12 Gene PDL1 Dako Panel**Introduction**: The Lung Cancer 12 Gene PDL1 Dako Panel is a diagnostic tool designed to assess lung cancer mutations and PD-L1 using FFPE tissue. In India, advanced NSCLC requires comprehensive biomarker testing (12-gene panel + PD-L1 Dako 22C3) for first-line therapy selection (TKIs for EGFR/ALK/ROS1, pembrolizumab for PD-L1 ≥50 percent). High morbidity from under-testing in rural/low-SES patients with late-stage disease, limited molecular/IHC labs, delayed precision therapy leading to poor survival. Per oncology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs PCR for 12-gene panel and IHC for PD-L1 Dako 22C3 over 1-2 days with high accuracy, valuable for personalized treatment in metastatic NSCLC. This diagnostic falls under cancer screening and targets patients with advanced lung adenocarcinoma, addressing accurate detection to guide targeted/immunotherapy and avoid ineffective chemo. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise biomarker assessment and improving lung cancer outcomes. Its FFPE-based approach ensures reliable mutation and expression analysis.**Other Names**: Lung Dako Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/histopathology/oncology, compliant with 2025 standards.**Historical Milestone**: Multi-gene + PD-L1 Dako standard; in India, expanding in precision oncology.**Purpose**: The test assesses 2 parameters including 12-gene panel to guide lung cancer assessment, detect mutations/PD-L1, inform targeted/immunotherapy.**Test Parameters**: 1. 12-Gene Panel, 2. PDL1 Dako 22C3.**Pretest Condition**: No fasting required; patients should have lung 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 smoking, stage, symptoms.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected biomarkers including wrong therapy, benefits of profiling, and no additional discomfort (uses existing block).**Procedural Considerations**: The test involves sample processing using PCR/IHC by trained personnel to ensure accurate scoring, avoid artifacts, and provide detailed report within 1-2 days 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 interpretation differences can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Actionable mutation or PD-L1 high indicates targeted/immunotherapy eligibility, necessitating specialist input.**Specialist Consultation**: Thoracic oncologists should be consulted for management.**Additional Supporting Tests**: NGS, full biomarker panel for confirmation.**Test Limitations**: 12-gene limited; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Lung Cancer Studies India 2023. |
