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CDKN2A Amplification Reference Standard (Gold Standard) | Precise Calibration Ensures Detection Reproducibility

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  • CBP40053

  • CBP40053

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Product Overview
   

CDKN2A (cyclin-dependent kinase inhibitor 2A) gene is a crucial tumor suppressor. Its encoded proteins, p16 and p14ARF, play a central role in cell cycle arrest by inhibiting cyclin-dependent kinases (such as Cdk4/Cdk6) and regulating the TP53 pathway (PMID: 23875803, 17055429, 27428416).Inactivation of this gene—including mutations, deletions, or promoter methylation—is one of the most common genetic events in human cancer. Notably, CDKN2A amplification is also a significant molecular event that may play a role in the development or resistance mechanisms of certain tumors, holding particular research and clinical significance in specific tumor subtypes.


To support high-quality research and assay development targeting this specific variant type, we proudly introduce our high-purity, precisely quantified CDKN2A Amplification Reference Standard. Derived from rigorously authenticated genomic DNA and precisely validated via digital PCR (DdPCR) technology to exhibit a copy number amplification of 4, this product serves as an indispensable reference material for fundamental research, companion diagnostic development, assay establishment and validation (e.g., NGS, qPCR), and laboratory quality control.



Product Features

 

1.Defined Genetic Background: Specifically targets the amplified state of the CDKN2A gene, distinct from wild-type, deletion, or mutation standards.

2.Precise Quantification: Absolutely quantified using high-accuracy digital PCR (ddPCR), confirming a target copy number of 4 to provide a reliable benchmark for quantitative assays.

3.High-Quality Genomic DNA: Supplied as purified genomic DNA with high integrity and compatibility with a wide range of downstream molecular workflows.

4.Comprehensive Quality Validation: Each batch is accompanied by a detailed Certificate of Analysis (COA), including:

*Concentration and Purity (A260/A280, A260/A230): Ensures DNA is free from protein, salt, or organic solvent contamination.

*DNA Electrophoresis Gel Image: Visually demonstrates DNA integrity with no significant degradation.

5.Stable Physical Form: Available as 1 μg lyophilized DNA or liquid DNA in a stabilized buffer—easy to use and aliquot.

6.Excellent Stability: Recommended storage at 2-8°C with a shelf life of up to 36 months, supporting long-term experimental planning.




Product Advantages


Enhances Research Accuracy & Comparability: When detecting CDKN2A amplification, using this reference standard as a positive control effectively corrects experimental systematic errors, ensuring consistency and comparability of results across different batches and laboratories.

Accelerate Assay Development & Optimization: Provides a ready-to-use positive reference for developing CDKN2A copy number variation detection protocols based on NGS, PCR, and other platforms. This aids in determining critical performance parameters such as detection limits, specificity, and reproducibility.

Strengthens Internal Laboratory QC:Regular incorporation of this standard into testing workflows enables continuous monitoring of stability and accuracy throughout the entire process—from nucleic acid processing to final data analysis—facilitating early detection of systemic deviations.

Relevant to Clinically Significant Tumor Types: CDKN2A alterations hold significant clinical importance in pancreatic cancer, head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), melanoma, and IDH-mutant glioma. This product offers direct application value for research in these fields.

Ready-to-Use Convenience:Pre-qualified and pre-quantified, saving significant time and cost associated with preparing in-house positive controls.



Intended Use & Applications


1.Molecular Pathology Research in Oncology:

Investigating the prevalence, clinical-pathological associations, and prognostic value of CDKN2A amplification across various cancer types (e.g., pancreatic cancer, lung cancer, glioma)

2.Companion Diagnostic Kit Development: Serving as a critical component for calibrating and validating the performance of commercial kits detecting CDKN2A copy number alterations.

3.Next-Generation Sequencing (NGS) Panel Validation: Serves as a positive control for copy number variation detection modules in NGS large panels or liquid biopsy panels to evaluate detection sensitivity and specificity.

4.QC for Traditional Molecular Assays: Used as an internal QC material for techniques like qPCR and multiplexed probe amplification to ensure the reliability of routine detection results.

5.Bioinformatics Analysis Workflow Validation: Provide Gold Standard data for bioinformatics teams developing and optimizing CNV (copy number variation) detection algorithms.

6.Laboratory Proficiency Testing & Standardization: Serve as third-party quality assessment samples or interlaboratory comparison samples to promote standardized testing results.



Why Choose CB-Gene?


Specialized Focus:We specialize in molecular reference standards with high research and clinical value—addressing the essential yet often overlooked need for CDKN2A amplification controls.

Technical Rigor: Absolute quantification via internationally recognized digital PCR, ensuring authoritative copy-number accuracy.

Transparent Quality:A complete Quality Analysis Certificate (COA) is provided, offering full visibility into purity, integrity, and sequence validation.

Reliable Supply Chain: Robust manufacturing processes and inventory control ensure stable long-term supply to support ongoing research.

Designed for Research Use: Clearly labeled For Research Use Only to support high-quality scientific output.



FAQ

 

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

This product originates from genomic DNA extracted from biological samples (cell lines) with fully characterized genetic backgrounds. Its genetic variations are either naturally occurring or induced, better simulating the complexity of real clinical samples.

How should this reference material be correctly used for NGS experiment quality control?

It is recommended to insert a certain number of this reference material as blind samples into each batch of clinical or research samples (e.g., 1 per 24 samples). After sequencing and bioinformatics analysis, evaluate whether the standard is correctly detected as amplified (copy number ~4) and whether its detected values fluctuate within the expected range. This monitors the stability of the entire NGS workflow.

What are the precautions for product storage and use?

Store dry and protected from light at 2-8°C. For use: centrifuge the tube at 5000 rpm for 1 minute, equilibrate to room temperature for 30 minutes, open the cap, mix gently by pipetting, and aliquot. After use, recap tightly, reseal with parafilm, and return to 2-8°C storage. If stored long-term (>6 months) in a frost-free refrigerator, minimal evaporation may occur for very small volumes (<25 µl). Reconstitute by adding nuclease-free water or TE buffer, mix thoroughly, re-centrifuge, and re-quantify concentration using a method like Qubit. This does not affect performance.

Do you offer standards for other types of genetic variations?

Yes. We are committed to providing a comprehensive matrix of standards covering various mutation types (point mutations, insertions/deletions, fusions, copy number variations) across multiple key cancer genes (e.g., EGFR, KRAS, BRAF, ALK, ROS1). Please contact us for the complete product catalog.


Related product list


Name

Catalog No.

BRCA1 Amplification  Reference Standard

CBP40051

BRCA1 Loss Reference Standard

CBP40031

BRCA2 Amplification  Reference Standard

CBP40052

BRCA2 Loss (CN=1) Reference Standard (Pair-P19)

CBP40129


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