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BRAF Mutation Kit
The TRUPCR® BRAF Mutation Kit is a CE-IVD real-time PCR assay designed for the qualitative detection of somatic mutations in the BRAF gene, particularly in codon 600. Optimized for FFPE, fresh, or frozen tumor tissue, the kit uses ARMS technology to selectively amplify mutant alleles even in a background of wild-type DNA. It can detect seven clinically relevant mutations in a single run with high sensitivity-down to 1% mutant DNA. The assay includes an extraction control to reduce false negatives and uses fluorescent probes for precise detection. Designed for use in molecular diagnostic workflows, the kit supports faster, more reliable, and cost-effective testing, enabling confident decision-making in oncology.
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This kit in detail
The TRUPCR® BRAF Mutation Kit is a CE-IVD real-time PCR assay designed for the qualitative detection of somatic mutations in the BRAF gene, particularly in codon 600. Optimized for FFPE, fresh, or frozen tumor tissue, the kit uses ARMS technology to selectively amplify mutant alleles even in a background of wild-type DNA. It can detect seven clinically relevant mutations in a single run with high sensitivity-down to 1% mutant DNA. The assay includes an extraction control to reduce false negatives and uses fluorescent probes for precise detection. Designed for use in molecular diagnostic workflows, the kit supports faster, more reliable, and cost-effective testing, enabling confident decision-making in oncology.
- Detects 7 codon 600 mutations in one PCR run
- Sensitivity down to 1% mutant allele frequency
- Includes extraction control for reliable results
- Compatible with most real-time PCR instruments
What is BRAF?
It is a gene that encodes a serine/threonine-protein kinase involved in the MAPK/ERK signaling pathway, which regulates cell growth, differentiation, and survival. When functioning normally, it contributes to controlled cellular signaling. However, certain mutations-especially in codon 600-can activate the gene constitutively, driving uncontrolled cell proliferation and tumorigenesis.
The most frequently observed mutation is V600E (valine to glutamic acid), which accounts for roughly 79% of BRAF-mutated melanomas. Other clinically relevant mutations include V600K, V600R, and V600M.
Role of BRAF Mutations in Cancer
Mutations in BRAF, particularly at codon 600, are key drivers in various cancers. These alterations lead to constant activation of downstream MAPK signaling, promoting unregulated tumor cell division and resistance to apoptosis. BRAF mutations are implicated in:
- Metastatic melanoma (~50% prevalence)
- Papillary thyroid carcinoma
- Colorectal cancer
- Non-small cell lung carcinoma (NSCLC)
- Hairy cell leukemia
- Adenocarcinoma of the lung
Because BRAF mutations are typically mutually exclusive with KRAS, NRAS, and EGFR mutations, their detection is essential for accurate tumor classification and targeted therapy selection.
About the TRUPCR® BRAF Mutation Kit
The TRUPCR® BRAF Mutation Kit is a CE-IVD assay designed for qualitative detection of mutations in codon 600 of the BRAF gene. Using ARMS PCR (Amplification Refractory Mutation System), the assay enables allele-specific amplification, targeting mutated sequences with high precision even in mixed populations of wild-type and mutant DNA.
Key highlights of the kit include:
- Detection of 7 mutations (including V600E, V600K, V600R, and V600M)
- Internal reference gene to ensure sample and extraction quality
- Use of FAM- and HEX-labeled fluorescent probes
- Compatibility with a broad range of real-time PCR platforms
The kit works on DNA extracted from FFPE, fresh, or frozen tumor tissue, making it highly versatile for clinical settings.
Principle and Workflow
- DNA Extraction: Isolate genomic DNA from FFPE, fresh, or frozen tumor samples.
- ARMS PCR Amplification: Specific primers selectively amplify mutated BRAF alleles using allele-specific technology.
- Real-Time Detection: Mutations are identified via fluorescent signal from FAM and HEX probes.
- Quality Control: An internal reference gene ensures extraction success and helps avoid false negatives.
- Result Interpretation: Mutations are reported qualitatively, with potential support from software-based curve analysis (if implemented in lab protocol).
The assay is optimized for routine diagnostic use and offers a simple, fast workflow with results available within a few hours.
Clinical Application
Detection of BRAF mutations is central to precision oncology. Identifying codon 600 mutations informs prognosis and eligibility for targeted therapies such as:
- BRAF inhibitors (e.g., vemurafenib, dabrafenib)
- MEK inhibitors (e.g., trametinib)
- Combination therapies in melanoma and NSCLC
This makes the TRUPCR® Mutation Kit ideal for:
- Hospital-based molecular diagnostic labs
- Oncology-focused research labs
- Routine mutation screening in solid tumors
With its CE-IVD status, the kit is validated for clinical use and supports personalized treatment strategies in cancer management.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Product Catalogus
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