Skip to main content
. Author manuscript; available in PMC: 2013 Mar 1.
Published in final edited form as: Pharmacogenomics. 2012 Mar;13(4):465–475. doi: 10.2217/pgs.12.2

Table 2.

US FDA warning label for clopidogrel and warfarin and FDA-approved testing platforms and assays for the analyte(s).

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.