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**Overview**: EGFR Mutation Panel**Introduction**: The EGFR Mutation Panel is a diagnostic tool designed to detect EGFR mutations using tissue (FFPE) or plasma samples. In India, non-small cell lung cancer (NSCLC) accounts for ~80 percent of lung cancers (~70,000 cases/year), with EGFR mutations prevalent in 30-50 percent of adenocarcinoma cases (higher in non-smokers, females, and Asians), guiding targeted therapy with EGFR TKIs (gefitinib, osimertinib). High morbidity from under-testing in rural/low-SES patients, limited NGS labs, delayed targeted therapy leading to poor progression-free survival. Per oncology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs NGS for exons 18-21 mutations over 1-2 days with high sensitivity/specificity, valuable for precision oncology in advanced NSCLC. This diagnostic falls under cancer mutation screening and targets lung cancer patients (especially adenocarcinoma), addressing accurate detection to guide first-line TKI therapy or clinical trials. With elevated morbidity due to under-testing, the test supports public health efforts by enabling precise treatment selection and improving survival. Its FFPE/plasma-based approach ensures reliable liquid biopsy capability.**Other Names**: EGFR Mut Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/oncology, compliant with 2025 standards.**Historical Milestone**: EGFR testing mandatory in NSCLC; in India, expanding in oncology centers.**Purpose**: The test detects 4 parameters including EGFR Exon 18 to guide mutation assessment, identify actionable variants, inform targeted therapy.**Test Parameters**: 1. EGFR Exon 18, 2. Exon 19, 3. Exon 20, 4. Exon 21.**Pretest Condition**: No fasting required; patients should have confirmed lung cancer diagnosis.**Specimen**: FFPE tissue block (0.5-2 cm³) or 3 mL plasma in EDTA tube, transported within specified times to maintain sample viability.Sample Stability: Indefinite (FFPE) or 8 hours RT / 7 days refrigerated / 6 months frozen (plasma), though immediate processing preferred.**Medical History**: Patients should provide details on cancer stage, histology, smoking history, prior therapy.**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/plasma 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.**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 EGFR mutations indicate TKI eligibility, necessitating specialist input. No mutations may require follow-up.**Specialist Consultation**: Medical oncologists 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, NSCLC Studies India 2023. |
