Now cleared for in vitro diagnostic use in the US and EU.

The world's first pharmacogenetic microarray-based test approved for clinical use. The AmpliChip CYP450 Test provides comprehensive coverage 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 for physicians in individualizing treatment selection and dosing for drugs metabolized through these genes.
More information/related links

Customer benefits

• Broad allelic coverage
  High built-in sensitivity analyzing 29 polymorphisms and mutations for the 2D6 gene and 2 polymorphisms for the 2C19 gene, thereby enabling more accurate determination of patient's the genotype and predicted phenotype (poor, intermediate, extensive, or ultra rapid metabolizer). Accurately genotypes over 99% of the world's population.
• All-in-One
  Tests for the 31 polymorphisms and mutations, including gene deletions and duplications, in a single assay.·The only test that also analyzes the functional status of gene duplications.
• Fast results
  Analysis can normally be completed within a single eight-hour shift after receipt of patient sample at the lab.
• Automatic Analysis
  Automatically determines genotype and predicted phenotype when used with Roche proprietary software.
• Gold Standards
  AmpliChip microarray-based tests combine Roche's patented PCR technology, the gold standard in nucleic acid amplification, with Affymetrix leading microarray technology.

Additional features

• 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.

More information/related links

• Find background information about microarray technology and the Cytochrome P450 gene family.
• Learn more about AmpliChip CYP450 Test in the US on www.amplichip.us.
• See also the AmpliChip Trailer video at www.roche.com/home/media/med_iam/med_iam_clip/med_iam_amplitrailer.htm.