KRAS Mutation Screening (Codons 12 & 13) Test
Short Name: KRAS Codon 12/13
Also known as: KRAS gene mutation analysis, KRAS codon 12 and 13 mutation test, KRAS mutation panel
KRAS Mutation Screening (Codons 12 & 13) Test test available at DNA Labs India for ₹10,500. Uses Sanger Sequencing on Tumor tissue (paraffin-embedded block or fresh biopsy) samples. Results in Reports are typically available within 7-8 days after the sample reaches the laboratory.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr Pasupathy Arumugam
Consultant Pathologist · Reg: 21521
Last reviewed: September 7, 2026
Overview
The primary purpose of KRAS mutation screening is to identify mutations in codons 12 and 13 of the KRAS gene, which are predictive of resistance to EGFR inhibitor therapy in colorectal cancer. It also aids in prognosis and can guide treatment selection in other cancers like lung and pancreatic cancer. The test helps avoid unnecessary use of expensive targeted therapies that are unlikely to be effective, thereby optimizing treatment outcomes and resource utilization.
- Test Code
- 6111
- CPT Code
- 81275
- ICD Code
- Z12.9
- Price
- ₹10,500
- Sample Type
- Tumor tissue (paraffin-embedded block or fresh biopsy)
- Result Time
- Reports are typically available within 7-8 days after the sample reaches the laboratory.
- Fasting Required
- No
- Method
- Sanger Sequencing
Sample Collection
No special preparation is required. However, a doctor's prescription is mandatory. Inform your doctor about any medications you are taking. For tissue samples, the biopsy procedure will be explained by your oncologist.
Method: Biopsy or surgical resection
Laboratory Analysis
The sample is collected via biopsy or surgical resection. You may experience mild discomfort, but the procedure is usually quick. Local anesthesia may be used if needed.
Report Delivery
After the biopsy, you may have mild soreness or bleeding at the site. Follow your doctor's instructions for wound care. The tissue sample will be sent to the laboratory for analysis.
Timeline: Reports are typically available within 7-8 days after the sample reaches the laboratory.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of KRAS mutation screening is to identify mutations in codons 12 and 13 of the KRAS gene, which are predictive of resistance to EGFR inhibitor therapy in colorectal cancer. It also aids in prognosis and can guide treatment selection in other cancers like lung and pancreatic cancer. The test helps avoid unnecessary use of expensive targeted therapies that are unlikely to be effective, thereby optimizing treatment outcomes and resource utilization.
How to Prepare
- Tissue sample must be placed in a sterile container with 10% neutral buffered formalin
- Do not freeze the sample
- Label the container with patient name, date, and site of biopsy
- Transport the sample to the lab within 24 hours at room temperature
- For FFPE blocks, send the block or unstained sections as per lab guidelines
Doctor's Notes
Reviewed by Dr Pasupathy Arumugam — MBBS, MD (Pathology) · Reg. No. 21521
"KRAS mutations in codons 12 and 13 are predictive biomarkers for anti-EGFR therapy response in metastatic colorectal cancer. Testing is essential before initiating cetuximab or panitumumab."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample with insufficient tumor cells (<20% tumor content)
- Sample decalcified using acid-based solutions
- Sample with extensive necrosis
- Sample not properly fixed or transported
- Inadequate labeling or missing requisition form
Understanding Your Results
Wild type (no mutation)
Patient may benefit from anti-EGFR therapy (cetuximab or panitumumab) in colorectal cancer. Continue standard treatment protocols.
Mutation in codon 12 (e.g., G12D, G12V)
Predicts resistance to anti-EGFR therapy. Alternative treatment options should be considered.
Mutation in codon 13 (e.g., G13D)
Generally associated with poor response to anti-EGFR therapy, though some studies suggest potential benefit in certain contexts. Clinical correlation required.
Consult your oncologist if you have been diagnosed with cancer and are considering targeted therapy. Also, consult if you have a family history of KRAS-associated cancers or if you experience new or worsening symptoms.
Limitations
- ⚠Only detects mutations in codons 12 and 13; other KRAS mutations (e.g., codon 61, 146) are not covered
- ⚠Requires adequate tumor tissue; not suitable for liquid biopsy
- ⚠Sanger sequencing has a sensitivity of ~20% mutant allele frequency; low-level mutations may be missed
- ⚠Results should be interpreted in conjunction with clinical and pathological findings
Risks & Considerations
- ●Biopsy procedure risks: bleeding, infection, or damage to surrounding tissue
- ●False-negative results due to low tumor content or technical issues
- ●Psychological impact of receiving a mutation-positive result
Interfering Factors
- ●Inadequate tumor content in the sample (<20%) may lead to false-negative results
- ●Decalcification of bone samples can degrade DNA quality
- ●Fixation in acidic solutions or prolonged formalin exposure can cause DNA cross-linking
- ●Contamination with normal tissue can dilute mutant alleles
- ●Rare KRAS mutations outside codons 12 and 13 are not detected by this test
Compare With Similar Tests
| Test | KRAS Mutation Screening (Codons 12 & 13) | EGFR Mutation Testing | BRAF Mutation Testing | MSI Testing | ALK Rearrangement Testing |
|---|---|---|---|---|---|
| Comparison | KRAS Mutation Screening (Codons 12 & 13) | EGFR mutations are common in NSCLC and predict response to EGFR TKIs. KRAS mutations are mutually exclusive and predict resistance. Both tests guide targeted therapy. | BRAF V600E mutations are associated with poor prognosis in colorectal cancer and may guide treatment. KRAS and BRAF mutations are usually mutually exclusive. | Microsatellite instability (MSI) is a marker for immunotherapy response. KRAS testing is independent of MSI status but both are used in colorectal cancer management. | ALK rearrangements are targetable in NSCLC. KRAS mutations are alternative drivers; testing helps select appropriate targeted therapy. |
Frequently Asked Questions
What is KRAS mutation screening?
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