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AR Amplification (CN=3) Reference Standard: Validated for NGS & ddPCR

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  • CBP20191D

  • CBP20191D

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Product Overview
   

The Androgen Receptor (AR) signaling pathway is central to the initiation, progression, and treatment resistance of prostate cancer. As a key member of the nuclear hormone receptor family, dysfunction of the AR gene, particularly AR gene amplification, is a major mechanism driving the development of castration-resistant prostate cancer (CRPC) and treatment failure. AR amplification leads to receptor overexpression and ligand-independent activation, driving tumor progression even in low-androgen environments.

To facilitate precise research into this phenomenon and ensure the reliability of detection results, we proudly present the AR Amplification (CN=3) Reference Standard (Pair-P6)_Male. This is a pair of rigorously characterized and validated genomic DNA reference standards, comprising a tumor sample with AR gene copy number of 3 (CN=3) and a matched normal sample with AR gene copy number of 1 (CN=1). This product provides researchers with a stable, traceable benchmark specifically designed for the development, validation, quality control (QC), and proficiency testing of AR gene copy number variation detection assays.


Core Product Information:

Product Name: AR Amplification (CN=3) Reference Standard (Pair-P6)_Male

Tumor Sample Cat. No.: CBP40147T

Normal Sample Cat. No.: CBP40147N

Product Form: Genomic DNA

Unit Size: 1ug (Tumor) + 1ug (Normal)

Intended Use: Research Use Only


Product Features

 

The design of this AR Amplification Reference Standard thoroughly addresses the complex needs of practical research applications, featuring the following distinct characteristics:

Defined Gene Copy Number Value: 

  • Tumor Sample (CBP40147T): AR gene copy number is definitively set at 3. This level mimics the common low-level amplification observed in prostate cancer patients, making it an ideal model for accurate detection.

  • Normal Sample (CBP40147N): AR gene copy number is definitively set at 1, serving as an internal reference and baseline control for experiments.

  • This "Tumor-Normal" paired design effectively eliminates interference from inter-individual genomic background variation, enabling more accurate result analysis.

Multi-Platform Technical Validation

The copy number values have been independently verified by two gold-standard platforms, ensuring authoritative and reliable data.

  • NGS Verified Value: 3

  • ddPCR Verified Value: 3.71 (This value falls within the expected margin of error for ddPCR, strongly confirming the CN=3 amplified status.)

  • This dual verification system ensures the standard's applicability across different technological platforms and the consistency of results.

High-Quality Genomic DNA

The product provides high-purity, high-integrity genomic DNA, ready for direct use in various downstream applications such as qPCR, ddPCR, and NGS library preparation, eliminating the need for tedious sample pre-processing and saving valuable research time.

Stable Physical & Shelf-Life Properties: 

  • Storage Condition: 2-8℃

  • Expiry Date: 36 months from the date of manufacture.
    Stable storage conditions and a long shelf-life ensure long-term consistency and comparability of experimental materials, facilitating continuous research.


Product Advantages


Choosing our AR Amplification Reference Standard offers significant advantages over ordinary reagents:

Enhances Reliability and Reproducibility of Results: Using a precisely characterized standard allows for effective calibration of your experimental system, ensuring comparability and reproducibility of results across different batches, operators, and laboratories, significantly enhancing research credibility.

Accelerates Assay Development and Optimization: When developing AR copy number detection assays based on qPCR, ddPCR, or NGS, this product serves as a positive control and calibrator, enabling rapid validation of method sensitivity, specificity, and limit of detection, shortening the method establishment cycle.

Superior Quality Control Tool: Using it as an internal control in every experimental run allows for real-time monitoring of process stability, enabling timely identification and elimination of errors caused by reagents, instruments, or operations, safeguarding the accuracy of routine testing data.

Enables Research into Tumor Heterogeneity: The defined CN=3 value helps researchers more accurately evaluate their assay's ability to detect low-level amplifications (common in tumor heterogeneity), driving deeper exploration into the biological significance of AR amplification.


Intended Applications


This AR Amplification (CN=3) Reference Standard is widely applicable in the following life science research and IVD-related fields:

  • AR Signaling Pathway Research: Used to study how AR amplification affects gene transcription, cell proliferation, and drug resistance.

  • Companion Diagnostic Assay Development: Serves as a critical raw material for developing diagnostic kits to monitor prostate cancer progression and prognosis.

  • Technical Platform Performance Verification: Used to evaluate and compare the performance of different NGS panels, ddPCR assays, or other molecular platforms in detecting AR copy number variations.

  • Laboratory Internal Quality Control System Establishment: Serves as part of a laboratory's quality management system to ensure long-term stability of clinical testing or research data.

  • Drug Discovery & Biomarker Analysis: Used in clinical trials for novel drugs targeting the AR pathway to screen enrolled patients or monitor changes in AR gene status during treatment.


Why Choose CB-Gene?


Expertise and Focus:We deeply understand the central role of AR in prostate cancer; our standards directly address the pain points in research and clinical detection.

Data-Driven, Dual Verification: We provide not just a product, but reliable data backed by dual-technology validation (NGS & ddPCR), giving you peace of mind.

Ready-to-Use Solution: The "paired sample" design philosophy provides a complete, ready-to-use experimental reference system, saving you the hassle of sourcing and validating your own control samples.

Stringent Quality Control: From raw material selection to the final product, every batch undergoes rigorous DNA electrophoresis, Sanger sequencing, and other QC processes (relevant certificates available for download), guaranteeing high standards and batch-to-batch consistency.

Comprehensive Technical Support: We are committed to providing customers with excellent product service. Detailed product data and clear application guidelines are your solid foundation for experimental success.


FAQ

 

Can this reference standard be used to validate detection methods for FFPE samples?

This product consists of high-quality genomic DNA with integrity superior to most FFPE samples. While it provides an important reference for FFPE DNA detection, it is important to note that due to differences in DNA quality, methods intended for FFPE samples may require additional optimization. We recommend using this standard as a benchmark for determining your assay's performance under "ideal conditions."

The ddPCR verified value is 3.71, not an integer 3. Is this normal?

This is completely normal and expected. Digital PCR performs absolute quantification by direct counting; its result (here 3.71) is a statistical output based on a massive number of droplets and will typically be close to, but not exactly, an integer. This value (3.71) unambiguously confirms the presence of AR gene amplification (>2) and is highly consistent with the CN=3 conclusion from NGS validation, precisely demonstrating the authenticity and accuracy of the standard's characterization.

How should the product be stored and handled?

Please store the product at 2-8°C. Before use, briefly centrifuge the tube to collect the contents at the bottom. It is recommended to handle the product under sterile conditions using sterile, DNase/RNase-free tips and tubes. To avoid repeated freeze-thaw cycles, prepare aliquots based on your experimental needs.

Besides AR amplification, does this standard provide information on variations in other genes?

This product is primarily characterized and validated for the specific AR gene copy number amplification (CN=3). For detailed information on other genomic loci, please refer to the sequencing analysis report provided with the product or contact our technical support team.

Can this reference standard be used for clinical diagnosis?

No. The product's "Intended Use" is clearly stated as "Research Use Only." It is not intended for direct use in clinical diagnostic procedures. If you have IVD development requirements, please contact our business team to discuss customized collaboration options.


 Call to Action

Visit our website or contact our customer service to learn more about the AR Amplification (CN=3) Reference Standard (Pair-P6)_Male (Cat.No: CBP40147T & CBP40147N), and to download the product Certificate of Analysis (COA) and technical documentation. Let our high-quality standards become your most trusted partner in cutting-edge prostate cancer research



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AR Normal Reference Standard_Male

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