Table 2.
Drug | Biomarker(s) | Label sections† | Date of FDA warning† | FDA-approved pharmacogenetic testing platforms and assays‡ | Effective date‡ |
---|---|---|---|---|---|
Clopidogrel | CYP2C19 | Boxed warning Warnings and Precautions Dosage and Administration |
March 2010 | Affymetrix GeneChip System 3000DX (Roche AmpliChip® CYP450 Test) | January 2005 |
AutoGenomics Infiniti™ Analyzer | November 2010 | ||||
| |||||
Warfarin |
CYP2C9 VKORC1 |
Precautions Dosage and Administration |
August 2007, updated January 2010 | Verigene® System | September 2007 |
AutoGenomics Infiniti Analyzer | January 2008 | ||||
Cepheid SmartCycler® Dx System (ParagonDx Rapid Genotyping Assay – CYP2C9 and VKORC1) | April 2008 | ||||
Osmetech Molecular Systems eSensor® XT-8 System | July 2008 | ||||
Roche Diagnostics LightCycler® Ver1.2 (TrimGen Corporation eQ-PCR™ LC Warfarin Genotyping Kit) | February 2009 | ||||
GenMark Diagnostics eSensor® XT-8 System (DNA Genotek Oragene-Dx collection device) | December 2011 |
US FDA drug label.
US FDA Center for Devices and Radiological Health Clinical Laboratory Improvement Amendments database.