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NRAS Mutation Kit
The TRUPCR® NRAS Mutation Kit is a CE-IVD real-time PCR assay designed for qualitative detection of oncogenic NRAS mutations in human DNA extracted from formalin-fixed paraffin-embedded (FFPE), fresh, or frozen tissue. The kit uses allele-specific ARMS PCR technology to selectively amplify mutant alleles in mixed wild-type/mutant samples. With the ability to detect 24 clinically relevant mutations in a single run, this test provides comprehensive profiling of key codons including 12, 13, 61, 117, and 146. An integrated extraction control helps eliminate false negatives, and the kit is compatible with most standard PCR platforms. With high sensitivity (1% mutant allele detection), the NRAS Mutation Kit is ideal for use in molecular diagnostics labs performing RAS panel testing in oncology.
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This kit in detail
The TRUPCR® NRAS Mutation Kit is a CE-IVD real-time PCR assay designed for qualitative detection of oncogenic NRAS mutations in human DNA extracted from formalin-fixed paraffin-embedded (FFPE), fresh, or frozen tissue. The kit uses allele-specific ARMS PCR technology to selectively amplify mutant alleles in mixed wild-type/mutant samples. With the ability to detect 24 clinically relevant mutations in a single run, this test provides comprehensive profiling of key codons including 12, 13, 61, 117, and 146. An integrated extraction control helps eliminate false negatives, and the kit is compatible with most standard PCR platforms. With high sensitivity (1% mutant allele detection), the NRAS Mutation Kit is ideal for use in molecular diagnostics labs performing RAS panel testing in oncology.
- Detects 24 NRAS mutations with single-run efficiency
- ARMS PCR enables selective amplification of mutant alleles
- Includes extraction control to reduce false negatives
- Works with FFPE, fresh, or frozen DNA on standard PCR systems
What is NRAS?
NRAS is one of three closely related RAS oncogenes (alongside KRAS and HRAS) that encode small GTPase proteins acting as molecular switches in key signaling pathways. These proteins cycle between active (GTP-bound) and inactive (GDP-bound) forms, regulating processes like cell growth, differentiation, and survival.
Mutations in NRAS disrupt this regulation by locking the protein in an active state, leading to constant stimulation of downstream signaling cascades. This persistent activation contributes to tumor development and progression, particularly in malignancies such as metastatic colorectal cancer (mCRC), melanoma, and hematologic cancers.
Role of NRAS Mutations in Disease
Oncogenic mutations in NRAS are known to cluster at conserved codons-especially 12, 13, 61, 117, and 146-resulting in impaired GTP hydrolysis. In colorectal cancer, approximately 2–7% of metastatic cases carry NRAS mutations. These variants are important because they are associated with resistance to EGFR-targeted therapies and represent a distinct molecular subset compared to KRAS-mutated tumors.
Beyond therapy resistance, emerging data suggest that mutations in the gene correlate with specific tumor localizations (e.g., left-sided colon tumors) and patient characteristics (e.g., female gender), indicating a unique biological profile. These findings emphasize the importance of including NRAS in any RAS mutation panel used for treatment stratification.
About the TRUPCR® NRAS Mutation Kit
The TRUPCR® NRAS Mutation Kit is a CE-IVD in vitro diagnostic test designed to identify somatic mutations within key hotspots of the gene using real-time PCR and ARMS technology. The kit includes:
- 11 mutation-specific assays targeting 24 clinically relevant variants
- An internal control covering a region without known polymorphisms
- Allele-specific primers and fluorescent probes (FAM, HEX)
- Protocols optimized for FFPE, frozen, or fresh tissue-derived DNA
This kit is engineered to deliver high sensitivity, with reliable detection down to 1% mutant allele frequency. It is ideal for labs conducting routine oncology panels, particularly in cases requiring EGFR therapy decision-making.
Principle and Workflow
- Sample Preparation: Extract genomic DNA from FFPE, frozen, or fresh tumor tissue.
- ARMS PCR Amplification: Use allele-specific primers to amplify only mutant sequences.
- Fluorescence Detection: Dual probes detect target variants in real time via FAM and HEX channels.
- Internal Quality Control: Extraction control ensures process reliability and minimizes risk of false-negative results.
- Result Interpretation: End-point fluorescence and amplification curves are used for qualitative analysis of mutation status.
The workflow is compatible with a wide range of real-time PCR platforms, requiring minimal hands-on time and offering results within a few hours.
Clinical Application
The TRUPCR® NRAS Mutation Kit provides essential data for the molecular characterization of tumors. Detection of NRAS mutations is increasingly standard in the management of metastatic colorectal cancer, especially prior to initiating EGFR inhibitor therapy.
Key applications include:
- RAS mutation screening in CRC
- Predictive biomarker testing in EGFR therapy pathways
- Molecular profiling in melanoma, AML, and thyroid cancers
- Integration into broader NGS or PCR-based oncology workflows
This assay enables personalized treatment decisions and contributes to high-confidence diagnostics in both centralized and decentralized lab settings.
Datasheets and regulatory documentation
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Product Catalogus
Frequently paired with this kit
Other assays and instruments lab teams add alongside the NRAS Mutation Kit.
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