AmpliChip CYP450 Test 

 
Registration Status

CE-IVD
Japan-IVD
US-IVD
Analysis of CYP2D6 and CYP2C19 genes
Comprehensive detection of gene variations – including deletions and duplications – for the CYP2D6 and CYP2C19 genes, which play a major role in the metabolism of an estimated 25 percent of all prescription drugs. This test helps clinicians determine therapeutic strategy and treatment dose for therapeutics metabolized by the CYP2D6 or CYP2C19 gene product.
Features and Benefits
 
Features
  • The first chip-based in vitro diagnostic with CE Mark certification and FDA clearance
  • The most comprehensive CYP2D6 and CYP2C19 analysis in a single test
Benefits
  • Detects up to 33 CYP2D6 alleles and 3 CYP2C19 alleles
  • Detects CYP2D6 gene duplication and deletions
  • AmpliTaq GOLD polymerase carry-over protection prevents cross-contamination of samples
  • Proprietary software enables the generation of customized reports containing genotype and predicted phenotype information
Intended Use
 
(CE-IVD, 1/2009, Rev. 6.0)
The AmpliChip CYP450 Test performs genotyping of two Cytochrome P450 genes and provides the predictive phenotype of the associated enzymatic activities, using DNA purified from human blood. The assay distinguishes 29 known polymorphisms in the CYP2D6 gene, including gene duplication and gene deletion, as well as two major polymorphisms in the CYP2C19 gene. Detection of these CYP2D6 polymorphisms results in the identification of 33 unique alleles, including seven CYP2D6 gene duplication alleles. This assay is intended for use as an aid for treatment choice and individualizing treatment dose for therapeutics metabolized primarily by CYP2D6 or CYP2C19 gene products. The Roche AmpIiChip CYP450 Test is intended to identify a patient's CYP2D6 and CYP2C19 genotype from genomic DNA extracted from a whole blood specimen. Information about CYP2D6 and CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2D6 or CYP2C19 gene product.

(US-IVD, 1/2009, Rev. 6.0)
The Roche AmpliChip CYP450 Test is intended to identify a patient's CYP2D6 and CYP2C19 genotype from genomic DNA extracted from a whole blood specimen. Information about CYP2D6 and CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2D6 or CYP2C19 gene product.
More Information
 
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