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NRAS Mutation Codon 12 13 & 61 Test

DNA Labs India | ISO 9001:2015 Certified

NRAS Mutation Codon 12 13 & 61 Test

Short Name: NRAS Mutation Test

Also known as: NRAS Gene Mutation Analysis, NRAS Codon 12/13/61 Sequencing, NRAS Oncogene Mutation Panel, NRAS Mutation Detection by PCR Sequencing

NRAS Mutation Codon 12 13 & 61 Test test available at DNA Labs India for ₹8,500. Uses PCR, Sequencing on Formalin Fixed Paraffin Embedded (FFPE) Tissue Block samples. Results in Results are typically available within 7-10 working days from receipt of a satisfactory specimen. Sample should be submitted by Tuesday 11 AM for reports by Monday. Delays may occur if specimen quality is insufficient and repeat testing is required.. Free home collection in 300+ cities across India.

OncologistAll Ages🏠 Home Collection

✍️ Written By

🩺 Medically Reviewed By

Dr Pasupathy Arumugam

Dr Pasupathy Arumugam

Consultant Pathologist · Reg: 21521

Last reviewed: September 7, 2026

Overview

The primary purpose of the NRAS Mutation Codon 12, 13 & 61 Test is to identify activating mutations in the NRAS gene that drive oncogenesis and influence treatment decisions. In metastatic colorectal carcinoma, NRAS mutation status determines eligibility for anti-EGFR targeted therapy. Patients with wild-type (unmutated) NRAS may benefit from cetuximab or panitumumab, while those with NRAS mutations are unlikely to respond and may experience adverse effects. The test also aids in prognosis assessment, as NRAS-mutant tumours may exhibit more aggressive biological behaviour. Additionally, NRAS mutation testing is relevant in melanoma, where it may guide selection of MEK inhibitor therapy, and in thyroid cancer and acute myeloid leukaemia for risk stratification and therapeutic planning.

Test Code
1321
CPT Code
81210
ICD Code
C20, C43, C73
Price
₹8,500
Sample Type
Formalin Fixed Paraffin Embedded (FFPE) Tissue Block
Result Time
Results are typically available within 7-10 working days from receipt of a satisfactory specimen. Sample should be submitted by Tuesday 11 AM for reports by Monday. Delays may occur if specimen quality is insufficient and repeat testing is required.
Fasting Required
No
Method
PCR, Sequencing
Step 1

Sample Collection

Ensure the FFPE tissue block contains a minimum of 10% tumour tissue as confirmed by a qualified pathologist. Complete the NGS Test Requisition Form (Form 40) with all required clinical details, patient history, and referring physician information. Verify the block has been properly fixed in 10% neutral buffered formalin for the recommended duration (6-72 hours).

Method: Tissue biopsy / Surgical resection specimen

Step 2

Laboratory Analysis

The specimen is typically obtained via core needle biopsy, excisional biopsy, or surgical resection. The tissue is processed and embedded in paraffin by the histopathology laboratory. The FFPE block is then selected and shipped at room temperature to DNA Labs India. No additional patient procedure is required for this test beyond the initial tissue collection.

Step 3

Report Delivery

After the FFPE block is received at the laboratory, DNA is extracted from the tumour-enriched area. PCR amplification targeting exons 2 and 3 of the NRAS gene (covering codons 12, 13, and 61) is performed, followed by Sanger sequencing or next-generation sequencing to identify mutations. The report is typically available within 7-10 working days and is delivered through the online portal, email, or WhatsApp.

Timeline: Results are typically available within 7-10 working days from receipt of a satisfactory specimen. Sample should be submitted by Tuesday 11 AM for reports by Monday. Delays may occur if specimen quality is insufficient and repeat testing is required.

Patient Instructions

1
Before the Test:No special preparation such as fasting is required for this test. The test is performed on an already-collected FFPE tissue specimen. Ensure your oncologist has completed the NGS Test Requisition Form (Form 40) and that the tissue block contains at least 10% tumour content as confirmed by pathological review.
2
During the Test:The NRAS Mutation test is a laboratory-based procedure performed on the submitted FFPE tissue block. The process involves DNA extraction from the tumour-enriched region, PCR amplification of NRAS exons 2 and 3, and subsequent DNA sequencing to detect mutations at codons 12, 13, and 61. No additional patient procedure is required during the testing process.
3
After the Test:After the test is completed, a detailed molecular pathology report is generated indicating the NRAS mutation status. This report will be shared with your referring oncologist who will interpret the results in the context of your overall clinical picture, other molecular test results, and treatment history. Further therapeutic decisions, including targeted therapy eligibility, will be based on this comprehensive evaluation.

About This Test

Who Should Get This Test

The primary purpose of the NRAS Mutation Codon 12, 13 & 61 Test is to identify activating mutations in the NRAS gene that drive oncogenesis and influence treatment decisions. In metastatic colorectal carcinoma, NRAS mutation status determines eligibility for anti-EGFR targeted therapy. Patients with wild-type (unmutated) NRAS may benefit from cetuximab or panitumumab, while those with NRAS mutations are unlikely to respond and may experience adverse effects. The test also aids in prognosis assessment, as NRAS-mutant tumours may exhibit more aggressive biological behaviour. Additionally, NRAS mutation testing is relevant in melanoma, where it may guide selection of MEK inhibitor therapy, and in thyroid cancer and acute myeloid leukaemia for risk stratification and therapeutic planning.

How to Prepare

  • Submit a formalin-fixed paraffin-embedded (FFPE) tissue block
  • Ensure the block contains at least 10% tumour tissue
  • Ship the specimen at room temperature
  • Duly filled NGS Test Requisition Form (Form 40) is mandatory
  • Include relevant clinical history and prior pathology reports
  • Label the specimen container clearly with patient name, ID, and date of collection

Doctor's Notes

Reviewed by — MBBS, MD (Pathology) · Reg. No. 21521

"NRAS mutation testing is essential in the molecular profiling of colorectal carcinoma, melanoma, and thyroid cancers. Determination of NRAS status at codons 12, 13, and 61 helps predict response to anti-EGFR therapy. Patients with NRAS mutations are generally resistant to cetuximab and panitumumab, making this test critical for treatment planning. An absence of NRAS mutation does not guarantee treatment response, as other mutations such as KRAS and EGFR must also be evaluated. I recommend this test for all patients diagnosed with metastatic colorectal cancer, advanced melanoma, or thyroid carcinoma before initiating targeted therapy."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeFormalin Fixed Paraffin Embedded (FFPE) Tissue Block
Sample VolumeMinimum 10% tumor tissue in block
ContainerFFPE tissue block container
Collection MethodTissue biopsy / Surgical resection specimen

Sample Stability

FFPE blocks stored at room temperature (15-30°C): Stable for several years if properly prepared
FFPE blocks stored at 2-8°C: Recommended for long-term archival storage
Avoid repeated freeze-thaw cycles of extracted DNA if applicable
Sample Rejection Criteria:
  • FFPE block with less than 10% tumour tissue
  • Incompletely filled or missing NGS Test Requisition Form (Form 40)
  • Specimen received without proper labelling or identification
  • Severely degraded or necrotic tissue with inadequate DNA yield
  • Specimen fixed in fixatives other than 10% neutral buffered formalin
  • Bone specimens subjected to prolonged decalcification without prior notification

Understanding Your Results

The NRAS Mutation Codon 12, 13 & 61 Test report indicates whether activating mutations are present at the specified codons of the NRAS gene. Results are reported as 'Mutation Detected' (positive) or 'No Mutation Detected' (wild-type/negative). The clinical significance of these results depends on the cancer type and the specific mutation identified.
📊

NRAS Mutation Detected at Codon 12, 13, or 61

High

📊

No NRAS Mutation Detected (Wild-type)

Moderate

📊

Indeterminate or Insufficient DNA

Requires Repeat Testing

⚠️ When to Consult a Doctor:

Consult your oncologist or treating physician if your NRAS test results are positive (mutation detected) to discuss the implications for your treatment plan, particularly regarding eligibility for anti-EGFR targeted therapy. If results are negative but you are not responding to current treatment, consult your doctor about additional molecular testing for KRAS, BRAF, EGFR, or other relevant biomarkers. Patients with a strong family history of colorectal cancer, melanoma, or thyroid cancer should discuss genetic counselling and comprehensive cancer gene panel testing with their physician.

Limitations

  • ⚠This test detects only specific mutations at codons 12, 13, and 61 of the NRAS gene; other rare NRAS mutations may not be identified
  • ⚠Results are dependent on the quality and tumour cellularity of the submitted FFPE tissue
  • ⚠A negative result does not exclude the presence of other oncogenic driver mutations (e.g., KRAS, BRAF, EGFR)
  • ⚠The analytical sensitivity may be limited for low-frequency mutant alleles below the detection threshold
  • ⚠This test is not a standalone diagnostic tool and must be interpreted in conjunction with clinical findings, histopathology, and other molecular tests

Risks & Considerations

  • ●This test itself poses no direct risk to the patient as it is performed on an already-collected tissue specimen
  • ●False-negative results may occur if tumour cellularity is low or DNA quality is poor
  • ●False-positive results due to sample contamination are rare but possible
  • ●Results may cause psychological distress; genetic counselling is recommended
  • ●Clinical decisions based solely on NRAS status without considering other molecular markers may lead to suboptimal treatment outcomes

Interfering Factors

  • ●Insufficient tumour content in the tissue block (less than 10% tumour cells)
  • ●Excessive DNA degradation due to prolonged fixation or improper storage of FFPE tissue
  • ●Presence of necrotic or heavily fibrotic tissue that reduces viable tumour DNA yield
  • ●Contamination of the specimen during collection or transport
  • ●Prior decalcification treatment on bone marrow or bone tissue samples

Compare With Similar Tests

TestNRAS Mutation Codon 12 13 & 61 TestKRAS Mutation Codon 12, 13 & 61 TestBRAF V600E Mutation TestExtended RAS Mutation Panel
ComparisonNRAS Mutation Codon 12 13 & 61 Test

Frequently Asked Questions

What is the NRAS Mutation Codon 12, 13 & 61 Test?
The NRAS Mutation Codon 12, 13 & 61 Test is a molecular genetic test that detects specific activating mutations in the NRAS gene at codons 12, 13, and 61. These mutations cause uncontrolled cell growth and are associated with several types of cancer including colorectal cancer, melanoma, and thyroid cancer. The test is performed using PCR and DNA sequencing on formalin-fixed paraffin-embedded (FFPE) tissue specimens.
Why is the NRAS Mutation Test important for cancer treatment?
NRAS mutation status is critical for treatment planning in metastatic colorectal cancer. Patients with NRAS mutations are resistant to anti-EGFR therapies such as cetuximab and panitumumab. Knowing the NRAS status helps oncologists avoid ineffective treatments and select appropriate targeted therapies, improving patient outcomes and preventing unnecessary side effects.
What sample is required for the NRAS Mutation Test?
The test requires a formalin-fixed paraffin-embedded (FFPE) tissue block. The tissue block must contain at least 10% tumour tissue as confirmed by a pathologist. The specimen is shipped at room temperature to the laboratory. A duly filled NGS Test Requisition Form (Form 40) is mandatory.
How much does the NRAS Mutation Codon 12, 13 & 61 Test cost at DNA Labs India?
The NRAS Mutation Codon 12, 13 & 61 Test costs INR 8500 at DNA Labs India. This includes the cost of the test, genetic counselling support, and digital report delivery. Free home sample collection is available for online bookings across major cities in India.
How is the NRAS Mutation Test performed?
The test involves extracting DNA from the FFPE tissue block, followed by PCR (Polymerase Chain Reaction) amplification of exons 2 and 3 of the NRAS gene, which cover codons 12, 13, and 61. The amplified DNA is then subjected to direct sequencing to identify any point mutations. The entire process is performed in a NABL-accredited molecular diagnostics laboratory.
What does a positive NRAS mutation result mean?
A positive result means that an activating mutation has been detected at one or more of codons 12, 13, or 61 of the NRAS gene. This indicates that the NRAS protein is constitutively active, driving cancer cell growth. In colorectal cancer, this typically means the patient will not respond to anti-EGFR therapy. Your oncologist will use this information to guide your treatment plan.
What does a negative NRAS mutation result mean?
A negative result means no mutations were detected at codons 12, 13, or 61 of the NRAS gene. In the context of colorectal cancer, this suggests the patient may be eligible for anti-EGFR therapy, provided other relevant mutations (such as KRAS) are also absent. However, a negative result does not guarantee treatment response, and additional molecular testing may be recommended.
How long does it take to get NRAS Mutation Test results?
Results are typically available within 7-10 working days from the date the laboratory receives a satisfactory specimen. Sample should be submitted by Tuesday 11 AM to receive reports by Monday. Delays may occur if the specimen quality is insufficient and repeat testing is required.
Is the NRAS Mutation Test covered by insurance?
The NRAS Mutation Test is covered by most private insurance plans in India, as it is a clinically essential molecular oncology test. Coverage under government schemes such as PMJAY, CGHS, ECHS, and ESIC may vary. It is recommended to check with your insurance provider or the empanelled facility for specific coverage details.
What is the difference between KRAS and NRAS mutation testing?
KRAS and NRAS are both members of the RAS gene family. Mutations in either gene activate the same RAS-MAPK signalling pathway and can cause resistance to anti-EGFR therapy. KRAS mutations are more common in colorectal cancer, while NRAS mutations occur in approximately 3-5% of cases. Both must be tested for comprehensive molecular profiling, as treatment decisions depend on the combined RAS mutation status.
Can the NRAS Mutation Test be done at home?
Since the NRAS Mutation Test requires a formalin-fixed paraffin-embedded (FFPE) tissue block, the specimen collection is performed in a hospital or pathology laboratory setting during a biopsy or surgical procedure. However, DNA Labs India offers free home sample collection for online bookings where applicable. Please note that for this test, the FFPE block from the pathology lab needs to be shipped to our facility, and free pickup service is available in select cities across India.
What other tests should be done along with the NRAS Mutation Test?
For comprehensive molecular profiling in colorectal cancer, KRAS Mutation Codon 12, 13 & 61 testing, BRAF V600E Mutation testing, EGFR Mutation Analysis, and Microsatellite Instability (MSI) testing are commonly recommended alongside the NRAS test. An Extended RAS Panel covering additional codons provides the most thorough assessment. Your oncologist will recommend the appropriate panel based on your cancer type and clinical stage.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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