Table 2.
Pharmacogenetic tests approved by the US FDA for IVD usea
| Gene(s) | Assay | Alleles interrogated | Company | Date approved |
|---|---|---|---|---|
| CYP2C9 and VKORC1 | Verigene® Warfarin Metabolism Test |
CYP2C9*2, *3, VKORC1 c.174-136C>T (1173C>T) |
Nanosphere, Inc. | September 2007 |
| INFINITI® Warfarin Assay |
CYP2C9*2, *3, VKORC1 c.-1639G>A |
AutoGenomics, Inc. | January 2008 | |
| eSensor® Warfarin Sensitivity Test |
CYP2C9*2, *3, VKORC1 c.-1639G>A |
GenMark Diagnostics, Inc. | July 2008; December 2011 | |
| eQ-PCR™ LC Warfarin Genotyping Kit |
CYP2C9*2, *3, VKORC1 c.-1639G>A |
TrimGen Corporation | February 2009 | |
| CYP2C19 | AmpliChip® CYP450 Test | *2, *3 | Hoffmann-La Roche Ltd | January 2005 |
| INFINITI® CYP2C19 Assay | *2, *3, *17 | AutoGenomics, Inc. | October 2010 | |
| Verigene® CYP2C19 Test | *2, *3, *17 | Nanosphere, Inc. | November 2012 | |
| Spartan RX CYP2C19 Assay | *2, *3, *17 | Spartan Bioscience Inc. | August 2013 | |
| xTAG® CYP2C19 Kit v3 | *2, *3, *17 | Luminex Molecular Diagnostics, Inc. | September 2013 | |
| CYP2D6 | AmpliChip® CYP450 Testb | *2–*11, *15, *17, *19, *20, *29, *35, *36, *40, *41, duplication | Hoffmann-La Roche Ltd | January 2005 |
| xTAG® CYP2D6 Kit v3 | *2–*11, *15, *17, *29, *35, *41, duplication | Luminex Molecular Diagnostics, Inc. | May 2013 |
Notes:
a
As listed on the US FDA IVD Product Database: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm
b
the CYP2D6 star (*) allele nomenclature for the AmpliChip® is based on the available nomenclature at the time of product release. The *41 allele reported by the AmpliChip® is not consistent with the current *41 haplotype nomenclature as it does not interrogate the 2988G>A variant that was discovered after the development of the Amplichip®.135
Abbreviations: FDA, Food and Drug Administration; IVD, in vitro diagnostic.