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KRAS 12/13 Mutation Detection (Exon 2 & 3), FFPE Tissue

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Molecular test for KRAS mutation.

₹8,584₹12,263

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KRAS 12/13 Mutation Detection (Exon 2 & 3) FFPE Tissue

  • Why is it done?
    • Detects mutations in codons 12 and 13 of the KRAS gene located in exons 2 and 3, which are among the most common oncogenic mutations found in human cancers
    • Identifies patients with colorectal cancer (CRC) who would NOT benefit from EGFR inhibitor therapy and have worse prognosis with these agents
    • Guides treatment selection for metastatic colorectal cancer (mCRC), particularly when EGFR-directed monoclonal antibodies (cetuximab, panitumumab) are being considered
    • Establishes prognostic information for pancreatic cancer, lung cancer, and other solid tumors with KRAS mutations
    • Performed on formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples obtained from surgical resection, biopsy, or other tissue collection procedures
    • Typically ordered at the time of initial cancer diagnosis or staging to inform therapeutic decisions and prognosis
  • Normal Range
    • NEGATIVE (Wild-type/Normal): No KRAS mutation detected in codons 12 or 13 of exons 2 and 3
    • POSITIVE (Mutant): KRAS mutation present in codon 12 or 13 - reported with specific mutation identified (e.g., G12C, G12V, G12D, G12A, G13D, etc.)
    • INDETERMINATE/INSUFFICIENT: Results cannot be determined due to inadequate tissue quality, low tumor cellularity, or technical issues requiring repeat testing or alternative specimen
    • Measurement Units: Qualitative presence/absence or percentage of mutant alleles (when using sensitive methods like digital PCR or next-generation sequencing)
    • Interpretation Context: Negative result generally indicates potential responsiveness to EGFR inhibitors in CRC; Positive result indicates resistance to anti-EGFR monoclonal antibodies
  • Interpretation
    • NEGATIVE Result (Wild-type KRAS): • Indicates tumor lacks KRAS mutations at codons 12/13 and may respond to EGFR-targeted therapy • In colorectal cancer: Eligible for cetuximab or panitumumab as treatment options • Associated with potentially better prognosis than KRAS-mutant tumors when treated with EGFR inhibitors • Does not exclude mutations in other KRAS codons (61, 117, 146) or other oncogenic pathways
    • POSITIVE Result (KRAS Mutation Present): • Indicates presence of activating KRAS mutation predictive of resistance to EGFR inhibitors • In colorectal cancer: Generally NOT a candidate for anti-EGFR monoclonal antibody therapy • Associated with significantly shorter overall survival when treated with EGFR-directed agents alone • May be candidate for alternative therapies including FOLFOX, FOLFIRI, or newer KRAS-targeted agents (e.g., sotorasib for G12C mutations) • Specific mutation type influences prognosis and treatment options (e.g., G12C mutations may respond to KRAS inhibitors)
    • Specific Mutation Interpretation: • G12C, G12V, G12D, G12A, G12S, G12R: Different amino acid substitutions with varying clinical implications • G13D: Another common codon 13 mutation with distinct prognostic significance • Each mutation type may have different sensitivity to emerging targeted therapies • Specific mutation informs discussion regarding clinical trial eligibility
    • Factors Affecting Interpretation: • Tumor cellularity: Low percentage of cancer cells may lead to false-negative results • Tissue fixation quality and age: May affect DNA integrity and test sensitivity • Test methodology: Different assays have varying sensitivity thresholds (conventional PCR vs. high-sensitivity methods) • Tumor heterogeneity: Presence of multiple clones may affect mutation detection • Prior treatment effects: May influence mutation landscape in previously treated specimens
  • Associated Organs
    • Primary Organ Systems: • Gastrointestinal tract (colon, rectum): Primary site for test utility; KRAS mutations found in 30-50% of colorectal cancers • Pancreas: KRAS mutations present in 75-90% of pancreatic adenocarcinomas • Lungs: Common in non-small cell lung cancer (NSCLC), particularly in adenocarcinomas • Liver: May be affected by metastatic disease from KRAS-mutant primary tumors
    • Cancers Associated with KRAS Mutations: • Colorectal cancer (CRC): Approximately 40-50% harbor KRAS mutations • Metastatic colorectal cancer (mCRC): Serves as primary indication for this test • Pancreatic ductal adenocarcinoma (PDAC): 75-90% mutation rate • Non-small cell lung cancer (NSCLC): 25-35% in adenocarcinomas • Biliary tract cancers: 20-40% with KRAS mutations • Appendiceal cancers: Frequently KRAS-mutant
    • Clinical Consequences of KRAS Mutations: • Constitutive activation of growth signaling pathways (MAPK/ERK pathway) • Enhanced cell proliferation and survival • Resistance to EGFR-directed therapy due to alternative pathway activation • More aggressive tumor behavior and accelerated progression • Increased metastatic potential • Generally associated with worse prognosis compared to KRAS wild-type tumors • Higher likelihood of developing treatment-resistant disease
    • Metastatic Sites Affected: • Liver: Most common site of metastasis in colorectal cancer • Peritoneum: Peritoneal carcinomatosis may occur • Lungs: Secondary metastatic site • Lymph nodes: Regional and distant nodal involvement • Distant organs: Based on primary tumor location and biology
  • Follow-up Tests
    • If KRAS 12/13 Negative (Wild-type): • Extended KRAS testing: May include codons 61, 117, 146 in select cases • BRAF mutation testing: Assess for concurrent BRAF V600E mutations • Microsatellite instability (MSI) or mismatch repair (MMR) testing • PD-L1 expression status: For immunotherapy eligibility assessment • No routine additional KRAS testing needed unless clinical suspicion remains
    • If KRAS 12/13 Positive (Mutant): • Extended KRAS sequencing: Full KRAS coding sequence if not already performed (codons 61, 117, 146) • BRAF V600E testing: Identify concurrent mutations • TP53 mutation status: Prognostic and therapeutic significance • PIK3CA mutations: May influence treatment strategy • Microsatellite instability (MSI) testing • Tumor mutational burden (TMB): For immunotherapy consideration • Consideration of KRAS-specific targeted therapy trials if G12C mutation identified
    • Complementary Molecular Testing: • Next-generation sequencing (NGS): Comprehensive multi-gene panel testing • Circulating tumor DNA (ctDNA/liquid biopsy): For monitoring treatment response • RNA expression profiling: Assess molecular subtypes and prognosis • Immunohistochemistry (IHC): For PD-L1, EGFR, or other protein biomarkers
    • Imaging and Clinical Follow-up: • CT imaging: Baseline and periodic surveillance for metastatic disease • Tumor markers (CEA, CA 19-9): Serial monitoring during treatment • Re-testing if disease progression occurs or at recurrence: To detect emerging mutations • Treatment response assessment: Imaging typically performed at 8-12 weeks after treatment initiation
  • Fasting Required?
    • NO - Fasting is NOT required
    • This is a tissue-based molecular test performed on stored/archival FFPE tissue samples, not a blood test, therefore fasting status does not apply.
    • Specimen Collection Requirements: • Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or unstained slides from prior biopsy or surgical resection • Minimum tissue requirements: Sufficient tumor tissue with adequate cellularity (typically ≥20% tumor cells recommended) • Tissue may be obtained from colon biopsies, colonoscopy samples, surgical resection specimens, or endoscopic ultrasound (EUS) biopsies • No special patient preparation needed
    • Pre-Test Instructions: • Ensure proper tissue specimen is available from pathology records • Confirm adequate tumor content and tissue quality • Avoid contamination of tissue samples • No medications need to be withheld • No diet restrictions • No activity restrictions
    • Specimen Handling: • FFPE tissue blocks must be properly labeled with patient identifiers • Tissue slides should be stored at room temperature (not frozen) • Protect from light exposure to prevent DNA degradation • Keep tissue blocks in original paraffin storage conditions • Ship according to laboratory specifications to maintain specimen integrity

How our test process works!

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