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**Overview**: KRAS NRAS Mutation Panel**Introduction**: The KRAS NRAS Mutation Panel is a diagnostic tool designed to detect KRAS/NRAS mutations using FFPE tissue. In India, KRAS/NRAS mutations occur in ~40-50 percent of colorectal cancers, ~20-30 percent of lung adenocarcinomas, and ~10-20 percent of pancreatic cancers, predicting resistance to EGFR inhibitors (cetuximab, panitumumab) in CRC and poor prognosis in multiple cancers. High morbidity from under-testing in rural/low-SES cancer patients, limited molecular labs, delayed targeted therapy or chemotherapy adjustment leading to treatment failure or progression. Per oncology practices aligned with ICMR and Indian Society of Medical Oncology guidelines, the test employs PCR for KRAS codons 12/13, NRAS codons 12/61, and mutation status over 1-2 days with high sensitivity, valuable for precision oncology in CRC, lung, and pancreatic cancers. This diagnostic falls under genetic cancer screening and targets patients with advanced solid tumors (CRC, NSCLC, pancreatic), addressing accurate detection to guide anti-EGFR avoidance or alternative regimens. With elevated morbidity due to underdiagnosis, the test supports public health efforts by enabling precise mutation profiling and improving cancer outcomes. Its FFPE-based approach ensures reliable tumor mutation detection.**Other Names**: KRAS NRAS Pnl.**FDA Status**: FDA approved, CLIA certified for molecular pathology/oncology, compliant with 2025 standards.**Historical Milestone**: KRAS/NRAS testing standard in CRC since 2009; in India, expanding in precision oncology.**Purpose**: The test assesses 5 parameters including KRAS Codon 12 to guide mutation detection, predict therapy resistance, inform targeted treatment.**Test Parameters**: 1. KRAS Codon 12, 2. KRAS Codon 13, 3. NRAS Codon 12, 4. NRAS Codon 61, 5. Mutation Status.**Pretest Condition**: No fasting required; patients should have confirmed malignancy.**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 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 KRAS/NRAS mutation predicts EGFR inhibitor resistance, necessitating specialist input.**Specialist Consultation**: Medical oncologists should be consulted for management.**Additional Supporting Tests**: BRAF, full NGS panel for confirmation.**Test Limitations**: Detects common codons; comprehensive approach required.**References**: Indian Journal of Medical Oncology 2024, Cancer Studies India 2023. |
