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Diagnostic Testing & Technology Report

Pharmacogenomics: Are Labs Believing the Hype?
February 2007


Main Article

Sidebar: Anticipated Benefits of Pharmacogenomic Testing

Sidebar: CYP450 Testing: Key Questions
BackBack

“The whole emphasis on personalized medicine has been way over-hyped. Eventually we’ll get there, but in regard to the promise of pharmacogenetics, the clinicians don’t know what to do with it.”

“The availability of [Roche’s AmpliChip CYP450 Test] has brought the field of pharmacogenentics to the threshold of influencing clinical practice,” wrote the study’s authors.

Sidebar: CYP450 Testing: Key Questions

  • What is the analytic (sensitivity, specificity, reproducibility, reliability)
    and clinical validity of tests that identify key CYP450 polymorphisms?
  • How well does CYP450 testing predict drug efficacy?
  • How well does CYP450 testing predict adverse drug reactions?
  • Do other factors, such as race/ethnicity, diet, other medications, affect test accuracy?
  • What are the harms associated with testing for CYP450 polymorphisms?
  • What are the management options for patients based on CYP450 test results?
  • Does the identification of the CYP450 genotypes lead to improved patient outcomes in terms of decreased symptoms/improved function, mortality/morbidity (avoiding adverse drug responses), or management decisions by patients and providers?
  • What are the harms associated with subsequent management options?

February 2007 - Table of Contents
DTTR February 2007 (full PDF issue)
Siemens, GE Build Diagnostic Powerhouses
FDA to Hold Meeting on IVDMIA Draft Guidance
Pfizer Buys Diagnostic Rights for Genizon’s Disease Markers
New ACOG Guidelines Urge Earlier Screening for Down Syndrome
FDA Approves Ortho-Clinical’s Chagas Disease Screening Test
Initiative Seeks Routine SCID Screening for Newborns
Genomic Health Gets United, Aetna Reimbursement for Oncotype DX
Pharmacogenomics: Are Labs Believing the Hype?
JAMA Study Links Expanded Medicare Reimbursement With Increased Colon Cancer Screening, Earlier Diagnosis
Epigenomics Chooses New CEO, Contracts With Centocor for Cancer Biomarkers
Luminex to Buy Tm Bioscience for $37.9M
BD Closes on $350m TriPath Acquisition
IVD Stocks Rose 20% in 2006 Led by Immucor, Cholestech, Digene
Molecular Diagnostics: The Conference

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