AI-Edigene® EGFR T790M Genomic DNA Reference Standard for Precision Oncology Research

Product Overview
   

The AI-Edigene® EGFR p.T790M Reference Standard Plus (Product Code: CBP10402) is a high-quality genomic DNA (gDNA) reference material specifically designed for the field of lung cancer genetic testing. With the widespread adoption of targeted therapy for non-small cell lung cancer (NSCLC), detection of the EGFR T790M mutation is critical for guiding treatment with third-generation EGFR-TKIs like Osimertinib. This product is developed using advanced gene-editing technology to introduce a precise genetic modification into a cell model, mimicking the authentic heterozygous EGFR T790M mutation found in patient samples. High-purity gDNA is then extracted from these cells. It serves as a stable, reliable, and well-characterized reference for the development, validation, quality control of molecular diagnostic kits, and the establishment and performance evaluation of laboratory testing workflows, ensuring accuracy and reproducibility of test results.

Product Features

 

Precisely Defined Genetic Alteration: 

Contains the specific EGFR c.2369C>T (p.T790M) mutation. It is characterized as a missense substitution, based on transcript ENST00000275493, at chromosome position chr7:55249071 (GRCh37). It is linked to COSMIC ID COSMIC6240, ensuring complete traceability.

Clear Heterozygous Model: The standard mimics a common heterozygous mutation state in tumors, with an defined allelic frequency of 50%. This provides a realistic challenge for assays to distinguish between wild-type and mutant alleles.

High-Quality Genomic DNA: The product is purified gDNA supplied in Tris-EDTA buffer for enhanced stability. It undergoes rigorous quality control, including DNA electrophoresis and Sanger sequencing, to guarantee sequence accuracy and nucleic acid integrity.

Convenient Stability: Supplied in a convenient unit size of 1μg. It should be stored at 2-8°C and has a long shelf life of 36 months from the date of manufacture, facilitating routine use and long-term storage.

Product Advantages

Advanced Technology: Unlike synthetic oligonucleotides or plasmid-derived standards, our product is derived from a genetically engineered cell line. The gDNA exists in a native chromatin context, more closely resembling clinical samples. This provides a more authentic performance assessment across the entire testing process, including DNA extraction, amplification, and sequencing.

Reliable and Reproducible Results: Each batch undergoes stringent quality control to ensure uniformity and accuracy in mutation call, zygosity, and allelic frequency. Users achieve highly consistent results, significantly enhancing the reliability of experimental data.

Ready-to-Use Solution: Users gain immediate access to a well-characterized reference material without the need for cell culture or sourcing highly variable clinical samples. This saves significant time and resources and eliminates the uncertainty associated with non-standardized samples.

Ideal QC Tool: Perfect for monitoring the sensitivity, specificity, and precision of detection systems, especially for highly sensitive technologies like ddPCR, NGS, and ARMS-PCR, ensuring laboratories can consistently detect low-frequency mutations.

Usage

• IVD Kit Development and Registration: Serves as a critical reference material for assessing the analytical performance (e.g., accuracy, precision, LoD) of diagnostic kits, supporting regulatory submissions.

• Laboratory Developed Test Validation: Used to validate the efficacy and reliability of in-house developed EGFR mutation detection assays.

• Routine Laboratory Quality Control: Functions as a positive control to monitor the stability and correctness of testing procedures in each run.

• Proficiency Testing: Can be used for internal competency assessment to ensure results meet industry standards.

• New Technology Platform Evaluation: Ideal for assessing and optimizing the performance of new sequencing platforms or detection technologies upon implementation.

Why Choose CB-Gene?

Choosing the AI-Edigene® EGFR p.T790M Reference Standard Plus means partnering with a trusted leader in quality. We are committed to providing the highest standard of reference materials for the precision medicine field through innovative gene-editing technology. Our product is not just a DNA sample; it embodies our commitment to rigorous quality control, technological excellence, and a deep understanding of customer needs. We ensure every detail—from cell line engineering to final packaging—is meticulously designed to help you enhance testing quality and accelerate research and diagnostic progress.

FAQ

 

Is this standard derived from a cell line? How does it differ from synthetic DNA standards?

Yes. This product is genomic DNA extracted from a human cell line that has been precisely engineered using CRISPR-based gene editing. Unlike synthetic oligonucleotides or plasmid DNA, cell line-derived gDNA possesses natural chromosome structure and epigenetics. It behaves more like a clinical sample during key steps like DNA extraction, fragmentation, and amplification, providing a more comprehensive and realistic evaluation of your assay's overall performance.

What is meant by "Heterozygous" and "Allelic Frequency of 50%"?

"Heterozygous" indicates that in the engineered cell line, one copy (allele) of the EGFR gene is wild-type (normal), while the other carries the c.2369C>T (T790M) mutation. "Allelic Frequency of 50%" means that across the cell population, the T790M-mutant allele constitutes 50% of the total EGFR alleles. This perfectly models a sample containing a mixture of mutant and normal cells, making it an ideal tool for assessing assay sensitivity.

How can I confirm the product I received meets specifications?

Each product vial is supported by a detailed Certificate of Analysis (COA). You can download the COA for your specific batch from our website, which includes key quality control data such as concentration, DNA integrity analysis (electropherogram), and Sanger sequencing chromatogram. You are also encouraged to verify the standard using your in-house methods, which should correlate with the COA data.

How should the product be stored and handled?

The product should be stored refrigerated at 2-8°C upon receipt. Briefly centrifuge the tube before use and handle it on ice. To avoid DNA degradation, avoid repeated freeze-thaw cycles. It is recommended to aliquot the product after dilution for long-term use.

 

Product Information	AI-Edigene® EGFR p.T790M Reference Standard Plus
Catalog No.	CBP10402
Format	Genomic DNA
Intended Use	Research Use Only
Unit Size	1ug
Sanger sequencing
Storage	2~8°C
Expiry	36 months from the date of manufacture

Technical Data

Product Information	AI-Edigene® EGFR p.T790M Reference Standard Plus
DNA Change	c.2369C>T
AA Change	p.T790M
Mutation type	Substitution - Missense
Zygosity	Heterozygous
Allelic Frequency	50%
Transcript	ENST00000275493
Cosmic ID	COSM6240
Chr position(GRCh37)	chr7:55249071
Buffer	Tris-EDTA

 

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