EML4-ALK E13:E20 Translocation Standard (CBP20020D)

Product Overview
   

The EML4(E13)-ALK(E20) Translocation Standard (CBP20020D) is a rigorously designed and validated genomic DNA product that specifically mimics the prevalent EML4-ALK gene fusion variant found in lung cancer patients. This product accurately recapitulates the breakpoint and fusion event joining exon 13 (E13) of the EML4 gene to exon 20 (E20) of the ALK gene, with specific breakpoints at genomic coordinates chr2:425****9 (+) and ch2:294****7 (-).

Supplied as 1μg of DNA in a stable Tris-EDTA buffer, this standard is formulated at a defined 20% Mutant Allele Frequency (%AF), closely mimicking real-world clinical samples. It is intended for Research Use Only and serves as an ideal tool for developing, validating, calibrating, and quality controlling ALK fusion detection assays (e.g., qPCR, digital PCR, NGS). The product is stable for 36 months from the date of manufacture when stored at 2-8°C.

Product Features

Well-Defined Fusion Type: 

Fusion Partners: Unambiguously defines the EML4 and ALK genes

Exon Combination: Precisely contains the E13:E20 exon combination, a clinically significant subtype.

Precise Genomic Coordinates: 

Left Breakpoint: chr2:425****9 (+)

Right Breakpoint: ch2:294****7 (-)

Clear genomic coordinates ensure unambiguous alignment and identification in Next-Generation Sequencing (NGS) data analysis, providing a gold standard for bioinformatics pipeline validation.

Standardized Mutant Allele Frequency: 20% Allele Frequency (AF): This carefully set frequency simulates low-level variants commonly found in tumor samples. It is crucial for assessing assay sensitivity and determining the Limit of Detection (LOD), ensuring your technology can reliably detect clinically relevant low-abundance mutations.

Rigorous Quality Control: The identity, purity, and integrity of the product are verified through multiple technical assays. Detailed information on DNA concentration, purity (A260/A280), DNA electrophoresis, and Sanger sequencing chromatograms are available for download via the Certificate of Analysis (COA), guaranteeing batch-to-batch consistency and impeccable quality.

Product Advantages

High Accuracy and Traceability: Defined breakpoint sequences and genomic coordinates ensure high reproducibility and traceability of results, facilitating inter-laboratory data comparison and method standardization.

Exceptional Stability and Convenience: Ready-to-use DNA format eliminates complex pre-processing like cell culture, saving time. Long-term stability at 2-8°C reduces storage costs and simplifies handling.

Mimics Real Clinical Scenarios: The 20% AF design directly addresses key challenges in detection, helping to validate assay performance with challenging samples and prevent false-negative results.

Comprehensive Quality Assurance: Access to complete COA and QC data provides confidence in your results and supports robust scientific research.

Intended Use

• Assay Development & Optimization: For developing and optimizing PCR, qPCR, ddPCR, and NGS panels targeting the EML4-ALK E13:E20 fusion.

• Laboratory Quality Control: Serves as a run-control material for monitoring the stability and accuracy of routine testing procedures.

• Assay Validation & Performance Verification: Used to establish sensitivity, specificity, accuracy, and LOD before implementing a new detection method.

• Inter-laboratory Comparison & Standardization: Acts as a known reference for comparing results across different laboratories and platforms, promoting testing standardization.

• Personnel Training & Proficiency Testing: Serves as a known sample for training new technicians and assessing their testing competency.

Why Choose CB-Gene?

Expertise and Focus:We specialize in the field of molecular diagnostic standards, with a deep understanding of the need for high-quality reference materials in precision medicine.

Transparent Technical Details: We provide exhaustive product specifications and raw QC data, ensuring complete transparency and informed decision-making.

Superior Product Design: Every detail, from the fusion type and breakpoint precision to the AF setting, is meticulously designed to meet your research and QC needs effectively.

Reliable and Stable Supply: Strict manufacturing protocols and stable storage conditions ensure consistent product quality and long-term, dependable availability.

Comprehensive Customer Support: We offer professional technical consultation and after-sales service, partnering with you to overcome challenges in genetic testing.

FAQ

What is the source of the DNA for this standard? Is it from a cell line or synthetically produced?

For stability and ethical reasons, CBP20020D is genomic DNA extracted from a genetically engineered stable cell line harboring the EML4-ALK E13:E20 fusion. This approach maintains the fusion in its native chromosomal context, better simulating the true biological state.

Is the 20% AF suitable for all detection platforms?

The 20% AF is a universal and challenging setting. It is well-suited for validating high-sensitivity platforms like NGS and ddPCR. It also functions perfectly as a positive control for conventional PCR. Please contact us regarding custom standards if you require specific AF levels (e.g., 5%, 50%).

How can I verify that the product I received matches the description?

Each vial is associated with a unique batch number. You can download the detailed Certificate of Analysis (COA) for that batch from our website, which includes Sanger sequencing chromatograms, electrophoresis data, concentration, and purity. You are also welcome to perform your own sequencing verification.

How should the product be stored and used?

Upon receipt, please store the product at 2-8°C (refrigerator). For use, perform dilutions or aliquoting under sterile conditions as required by your experiment to maintain DNA integrity and avoid repeated freeze-thaw cycles.

Can this standard be used for diagnostic reagent registration and approval?

This product is clearly labeled "For Research Use Only." While it excels as a tool for analytical performance evaluation, if intended for registration and approval of In Vitro Diagnostic (IVD) reagents, please verify the specific regulatory requirements for reference materials in your region. We can provide relevant technical documentation to support your application.

Technical Data

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If you have any questions, please feel free to contact us at sales@cb-gene.com