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AmpliChip CYP450 Test (CE-IVD and FDA-IVD)

The world's first pharmacogenetic microarray-based test approved for clinical use.

The AmpliChip CYP450 Test provides 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% of all prescription drugs. It is intended to be an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics metabolized by the CYP2D6 or CYP2C19 gene product.

Customer benefits

  • Broad allelic coverage
    High built-in sensitivity analyzing 29 polymorphisms for the CYP2D6 and CYP2C19 genes, thereby enabling more accurate determination of patient's genotype and predicted phenotype (CYP2D6: poor, intermediate, extensive, or ultra rapid metabolizer; CYP2C19: poor, extensive metabolizer) in a single assay. The only test that also analyzes the functional status of gene duplications. Over 99% genotype identification accuracy.
  • .
  • Fast results
    Analysis can normally be completed within a single eight-hour shift after receipt of patient blood sample at the lab.
  • Automatic Analysis
    Automatically determines genotype and predicted phenotype (CYP2D6: poor, intermediate, extensive, or ultra rapid metabolizer; CYP2C19: poor, extensive metabolizer) using Roche proprietary software.
  • Gold Standards
    AmpliChip microarray-based tests combine Roche's patented PCR technology, the gold standard in nucleic acid amplification, with leading microarray technology from Affymetrix.
  • Computer-assisted analysis
    Results are obtained and interpreted by computer analysis performed on a scan showing the pattern of hybridization of the patient sample to a series of probes (arrayed on the glass substrate) that are specifically complementary to either wild-type or mutant sequences.

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