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**Overview**: Cancer Lung Gene Panel**Introduction**: The Cancer Lung Gene Panel is a diagnostic tool designed to screen for lung cancer mutations using FFPE tissue samples. In India, lung cancer is a leading cause of cancer mortality (~70,000 new cases/year), with non-small cell lung cancer (NSCLC) predominant (85 percent), and actionable mutations (EGFR 20-40 percent in non-smokers/adenocarcinoma, ALK 3-7 percent, ROS1 1-2 percent, KRAS 20-30 percent) guiding targeted therapy. High burden in urban males/females due to tobacco, air pollution, cooking smoke in rural women. High morbidity from underdiagnosis of mutations in rural/low-SES patients, limited NGS labs, delayed EGFR/ALK inhibitors leading to poor survival. Per molecular pathology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs NGS for mutation analysis over 1-2 days with high sensitivity/specificity, valuable for precision oncology in advanced NSCLC. This diagnostic falls under genetic cancer screening and targets lung tumor tissue, addressing accurate detection to guide TKIs or clinical trials. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise treatment selection and improving outcomes. Its FFPE-based approach ensures reliable detection.**Other Names**: Lung Gene Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/oncology, compliant with 2025 standards.**Historical Milestone**: NGS panels for lung cancer; in India, growing in oncology centers.**Purpose**: The test screens for 4 parameters including EGFR to guide lung cancer assessment, identify actionable mutations, inform targeted therapy.**Test Parameters**: 1. EGFR, 2. ALK, 3. ROS1, 4. KRAS.**Pretest Condition**: No fasting required; patients should have confirmed lung cancer diagnosis with FFPE tissue available.**Specimen**: FFPE tissue block (0.5-2 cm³), transported within specified times to maintain sample viability.Sample Stability: Indefinite when properly stored (paraffin-embedded blocks stable long-term).**Medical History**: Patients should provide details on cancer type/stage, smoking history, prior therapy, family cancer history.**Consent**: Written informed consent is required, detailing the test's purpose, potential risks of untreated actionable mutations including poor response, benefits of profiling, and minimal discomfort (tissue already collected).**Procedural Considerations**: The test involves sample processing using NGS 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, and store kits according to manufacturer specifications to ensure reliability.**Factors Affecting Result Accuracy**: Poor tissue quality, low tumor content, or delays can affect results. Correlation with clinical evaluation or additional testing is recommended to confirm findings.**Clinical Significance**: Actionable mutations indicate targeted therapy eligibility, necessitating specialist input. No mutations may require follow-up.**Specialist Consultation**: Medical oncologists or pulmonologists should be consulted for management.**Additional Supporting Tests**: IHC or FISH for confirmation.**Test Limitations**: Covers hotspots only; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Lung Cancer NGS Studies India 2023. |
