General Session 4: Pharmacogenomics

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General Session 4 Pharmacogenomics
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FDA Pharmacogenomic Guidances

• April 2003, CDRH Multiplex Tests for Heritable
  DNA Markers, Mutations and Expression
  PatternsDraft Guidance for Industry and FDA
  Reviewers. http//www.fda.gov/cdrh/oivd/guidance/1
  210.pdf
• March 2004, CDER Pharmacogenomic Data
  Submissions. http//www.fda.gov/cber/gdlns/pharmd
  tasub.htm
• April 2005, CDER/CDRH/CBER/OCP Drug-Diagnostic
  Co-development Concept Paper http//www.fda.gov/cd
  er/genomics/pharmacoconceptfn.pdf

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Roche AmpliChip CYP450 Test (CDRH de novo 510(k)
K042259)

• Genotypes two cytochrome P450 genes (29
  polymorphisms in CYP2D6 gene, 2 in CYP2C19) to
  provide the predictive phenotype of the metabolic
  rate for a class of therapeutics metabolized
  primarily by CYP2D6 or CYP2C19 gene products.
  The phenotypes are
• (1) Poor metabolizers (3) Extensive
  metabolizers
• (2) Intermediate metabolizers (4) Ultrarapid
  metabolizers
• Cytochrome P450s are a large multi-gene family of
  enzymes found in the liver, and are linked to the
  metabolism of approximately 70-80 of all drugs.
  Among them, the polymorphic CYP2D6 and CYP2C19
  genes are responsible for approximately 25 of
  all CYP450-mediated drug metabolism. A
  polymorphism in these enzymes can lead to an
  excessive or prolonged therapeutic effect or
  drug-related toxicity after a typical dose by
  failing to clear a drug from the blood or by
  changing the pattern of metabolism to produce
  toxic metabolites.

http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfPMN/pmn.cfm