Table 4.

List of genetic tests cleared by the Center for Devices and Radiological Health, FDA.42, 43

Gene	Trade name	Manufacturer	Allele variants detection	DNA source	Approximate turnaround time
CYP2D6	xTAG CYP2D6 Kit v3	Luminex Molecular Diagnostics	*1, *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *29, *35, *41, and duplication	Whole blood	8–12 h
	Roche AmpliChip CYP450 microarray	Roche Molecular Systems	*1, *2, *3, *4, *5, *6, *7, *8, *9,*10, *11, *15, *17, *19, *20, *29, *35, *36, *40, *41, *1XN (duplication), *2XN, *4XN, *10XN, *17XN, *35XN, *41XN	Whole blood	6 h
CYP2C19	Spartan RX CYP2C19 Test System	Spartan Bioscience	*1,*2, *3, *17	Buccal swab	1 h
	Verigene CYP2C19 Nucleic Acid Test	Nanosphere	*1, *2, *3, *17	Whole blood	2.5 h
	INFINITI CYP2C19 Assay	AutoGenomics	*1, *2, *3, *17	Whole blood	8 h44
	Roche AmpliChip CYP450 microarray	Roche Molecular Systems, Inc.	*1, *2, *3, *17	Whole blood	6 h
CYP2C9 and VKORC1	eSensor warfarin sensitivity test and XT‐8 instrument	GenMark Diagnostics/ Osmetech Molecular Diagnostics	*2, *3, [*4, *5, *6, *11, *14, *15, *16],a and VKORC1 ‐1639 G>A	Saliva Whole blood	3.5 h
	eQ‐PCR LC warfarin genotyping kit	TrimGen Corporation	*2, *3, and VKORC1 ‐1639 G>A	Buccal swab Whole blood	1.5 h 2 h
	Gentris Rapid Genotyping Assay ‐ CYP2C9 & VKORC1	ParagonDx, LLC	*2, *3, and VKORC1 1173 C>T	Saliva	1.5 h42
	INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin	AutoGenomics	*2, *3, and VKORC1 ‐1639 G>A	Whole blood	10.5 h42
	Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System	Nanosphere	*2, *3, and VKORC1 ‐1639 G>A	Whole blood	1.5 h45

FDA, Food and Drug Administration.

^aThese variants are part of an extended panel, which is not FDA‐cleared.