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PGX-CYP2D6 XL StripAssay and CNV (CopyNumberVariation) Assay

PGX-CYP2D6 XL StripAssay and CNV (CopyNumberVariation) Assay

PGX-CYP2D6 XL StripAssay and CNV (CopyNumberVariation) Assay

Product catalog summary
Overview of CYP2D6 and Drug Metabolism: The cytochrome P450 2D6 (CYP2D6) enzyme is crucial in metabolizing over 25% of commonly used drugs. Variants in the CYP2D6 gene can lead to different enzymatic activities, affecting drug response and potentially causing adverse effects or suboptimal therapeutic outcomes.
Pharmacogenetic Testing: The ViennaLab PGX-CYP2D6 XL StripAssay® and CYP2D6 RealFast™ CNV Assay are designed to identify genetic variants and copy number changes in the CYP2D6 gene. These assays help determine a patient's metabolizer status, which is essential for optimizing drug choice and dosage.
Assay Details:
  • PGX-CYP2D6 XL StripAssay®: Detects prevalent CYP2D6 alleles, providing insights into enzyme function ranging from no function to normal function.
  • CYP2D6 RealFast™ CNV Assay: Identifies gene deletions or duplications, indicating no function or increased function, respectively.
Key Features: The assays offer a cost-efficient, rapid, and straightforward workflow, enhancing treatment efficacy and reducing adverse events through personalized medicine.
Clinical Implications: Comprehensive CYP2D6 genotyping supports pharmacogenetic guidelines recommending dose adjustments for various drugs, thereby improving patient outcomes.
Technical Workflow: The process involves DNA extraction from EDTA blood, PCR, reverse hybridization, and real-time PCR to generate a comprehensive report on CYP2D6 metabolizer status.
References: The document cites studies and guidelines from reputable sources, including the Clinical Pharmacogenetics Implementation Consortium, to support the clinical utility of the assays.
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Catalog excerpts

PGX-CYP2D6 XL StripAssay and CNV (CopyNumberVariation) Assay-1

Determination of genetic variants and copy number changes associated with poor, intermediate or ultra-rapid CYP2D6 metabolizer status. Cytochrome P450 2D6 and drug metabolism The cytochrome P450 2D6 (CYP2D6) is a liver enzyme involved in the metabolism of more than 25% of the most frequently used drugs in the clinical field. Variants of the highly polymorphic CYP2D6 gene are associated with altered enzymatic function, ranging from a complete lack of activity to an ultrarapid metabolization of drugs. This altered CYP2D6 activity causes an interindividual variability in drug-response. Patients with a defective or over-active CYP2D6 enzyme are either at risk to develop severe adverse events or do not reach the therapeutic window for effective treatment with a specific drug. Hence, pharmacogenetic guidelines recommend a CYP2D6-related dose-adjustment for numerous drugs. The ViennaLab PGX-CYP2D6 XL StripAssay® in combination with the CYP2D6 RealFast™ CNV Assay identifies patients with an altered CYP2D6 enzyme function. Comprehensive CYP2D6 genotyping optimizes the choice of medication and/or the adjustment of drug dosage and consequently reduces the risk of adverse events or lowered treatment efficacy. Key features • Comprehensive CYP2D6 analysis • PGX-CYP2D6 XL StripAssay® for detection of the most prevalent CYP2D6 alleles • CYP2D6 RealFast™ CNV Assay for identification of CYP2D6 deletions or duplications • Cost-efficient technologies • Rapid and simple workflow C € 11 VP I CYP2D6 RealFast™ CNV Assay: 7-420 (100 reactions) Order information: • PGX-CYP2D6 XL StripAssay®: 4-770 (20 tests)

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PGX-CYP2D6 XL StripAssay and CNV (CopyNumberVariation) Assay-2

«NNA ESTABLISHED INNOVATIONS IN DIAGNOSTICS Comprehensive CYP2D6 analysis with ViennaLab Assays Single variants or a combination of variants in the CYP2D6 gene define a CYP2D6 allele. The PGX-CYP2D6 XL StripAssay® detects the most common CYP2D6 alleles within the European population.1 In addition, the CYP2D6 RealFast™ CNV Assay determines the CYP2D6 gene copy number. The combination of both assays provides a comprehensive picture of the CYP2D6 metabolizer status of an individual. Reporting is based upon the activity score system, where each allele is assigned to an activity value, corresponding...

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