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**Overview**: OncoPro Lung Basic Panel**Introduction**: The OncoPro Lung Basic Panel is a diagnostic tool designed to screen for lung cancer mutations using FFPE tissue. In India, lung adenocarcinoma harbors actionable drivers (ALK ~5-10 percent, ROS1 ~2-3 percent, EGFR ~30-50 percent in nonsmokers), guiding TKIs with superior outcomes over chemotherapy. High morbidity from under-testing in rural/low-SES patients with advanced NSCLC, limited molecular labs, delayed crizotinib/osimertinib leading to rapid progression or poor survival. Per oncology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs PCR for 5 key mutations (ALK1, ROS1, EGFR Exon 19 Deletion, EGFR L858R, EGFR T790M) over 1-2 days with high sensitivity, valuable for basic precision oncology in NSCLC. This diagnostic falls under genetic cancer screening and targets NSCLC adenocarcinoma patients, addressing accurate detection to guide targeted therapy and avoid ineffective chemo. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling essential mutation profiling and improving lung cancer outcomes. Its FFPE-based approach ensures reliable hotspot detection.**Other Names**: Lung Basic Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/oncology, compliant with 2025 standards.**Historical Milestone**: Basic driver panel standard in India since 2010s.**Purpose**: The test assesses 5 parameters including ALK1 to guide lung cancer mutation screening, identify actionable alterations, inform TKI therapy.**Test Parameters**: 1. ALK1, 2. ROS1, 3. EGFR Exon 19 Deletion, 4. EGFR L858R, 5. EGFR T790M.**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, histology, stage.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of undetected mutation including wrong therapy, benefits of profiling, and no additional discomfort (uses existing block).**Procedural Considerations**: The test involves sample processing using PCR by trained personnel to ensure sterile technique, avoid contamination, and interpret results 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**: Positive ALK/ROS1/EGFR indicates TKI eligibility, necessitating specialist input.**Specialist Consultation**: Thoracic oncologists should be consulted for management.**Additional Supporting Tests**: PD-L1 IHC, full NGS for confirmation.**Test Limitations**: 5-gene limited; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Lung Cancer Studies India 2023. |
