VeriDose® CYP2D6 CNV Panel – Enhancing Precision in Pharmacogenomics

What’s Included in the CYP2D6 CNV Panel?

The VeriDose® CYP2D6 CNV Panel by Agena Bioscience™ is a highly advanced molecular assay designed to detect copy number variations (CNVs) across seven key regions of the CYP2D6 gene. In a single-well format, it interrogates 22 distinct loci commonly associated with clinically significant CYP2D6 variants, enabling simultaneous detection of CNVs and hybrid alleles. This streamlines complex pharmacogenomic workflows, increasing both accuracy and efficiency.

The panel is designed to work in tandem with Agena’s genotyping assays, delivering a dual-layer PGx solution that combines CNV and SNP analysis in one integrated process.

The Role of CYP2D6 CNVs and Hybrid Alleles in Drug Metabolism

The CYP2D6 enzyme metabolizes approximately 25% of commonly prescribed drugs, including antidepressants, beta-blockers, and opioids. Structural variations—such as gene deletions, duplications, and hybrid alleles like *13, *68, or exon 9 rearrangements—can dramatically impact a patient’s drug response:

• Ultra-rapid metabolizers (due to duplications) may require lower dosages to avoid toxicity.

• Poor metabolizers (due to deletions or non-functional hybrids) may not respond to treatment at all.

Hybrid alleles are particularly complex and underdetected—affecting up to 45% of individuals in certain populations—making accurate identification essential for safe and effective drug therapy.

Key Features of the VeriDose® CYP2D6 CNV Panel

• Comprehensive Gene Coverage
  Targets seven key regions of the CYP2D6 gene, including areas prone to hybrid formation, minimizing the risk of misclassification.

• Hybrid Allele Detection
  Identifies clinically relevant hybrid alleles that many standard CNV tests miss.

• Single-Well Workflow
  Reduces hands-on time and pipetting errors, improving lab efficiency.

• Seamless Integration
  Works alongside Agena’s genotyping panels for a full pharmacogenomic profile (CNVs + SNPs).

• Streamlined Testing
  Eliminates the need for reflex testing or multiple assays, consolidating results into one run.

How It Works: Simplified 4-Step Workflow

1. DNA extraction from the patient sample

2. Single-well amplification using the CYP2D6 CNV Panel

3. CNV and hybrid allele detection via mass spectrometry

4. Data interpretation through integrated software aligned with genotyping results

This unified approach gives laboratories a complete view of a patient’s CYP2D6 copy number and SNP profile, in one workflow.

Clinical Applications and Value

The CYP2D6 CNV Panel contributes directly to personalized medicine by enabling precise determination of metabolizer status—from poor to ultra-rapid. This allows healthcare providers to tailor drug regimens for:

• Improved safety

• Increased efficacy

• Reduced treatment costs

It is especially impactful in specialties such as:

• Psychiatry

• Cardiology

• Pain management

Furthermore, by detecting hybrid alleles often missed in traditional testing, the panel ensures equitable and accurate pharmacogenomic results across ethnically diverse populations.

Ideal for:

• Clinical diagnostics labs

• Translational research centers

• Pharmaceutical clinical trial teams

• Routine PGx screening programs

Conclusion: A New Standard in PGx CNV Testing

The VeriDose® CYP2D6 CNV Panel represents a leap forward in pharmacogenomic testing. Its accurate detection of CNVs and hybrid alleles, combined with an efficient, single-well workflow, positions it as a vital tool for any lab embracing the future of precision medicine.