Table 1.
FDA Cleared or Approved PGx Tests (nucleic acid based-tests) (Excerpted from FDA Nucleic Acid based tests on 06/26/16 at (available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.htm) and List of Cleared or Approved Companion Diagnostic Devices (nucleic acid based-tests) (available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm).
| PGx or Companion Diagnostic Test (Manufacturer) | Associated Medication | Genetic Variants Analyzed |
|---|---|---|
| Kit v3 (Luminex Molecular Diagnostics, Inc.) | Imatinib | CYP2D6 *1-*11, *15, *17, *29, *35, *41, and duplication genotypes |
| Spartan RX CYP2C19 Test System (Spartan Bioscience, Inc.) | Multiple | CYP2C19 *2, *3, *17 |
| Verigene CYP2C19 Nucleic Acid Test (Nanosphere, Inc.) | Multiple | CYP2C19 *2, *3, *17 |
| INFINITI CYP2C19 Assay (AutoGenomics, Inc) | Multiple | CYP2C19 *2, *3, *17 |
| Invader UGT1A1 Molecular Assay (Third Wave Technologies Inc.) | Multiple | UGT1A1* 1 (TA6) and *28 (TA7) alleles |
| Roche AmpliChip CYP450 microarray (Roche Molecular Systems, Inc.) | Multiple | CYP2C19 *1, *2, *3 CYP2D6 |
| eSensor Warfarin Sensitivity Saliva Test (GenMark Diagnostics) | Warfarin | CYP450 2C9 *2,*3 VKORC1 (−1639G>A) |
| eQ-PCR LC Warfarin Genotyping kit (TrimGen Corporation) | Warfarin | CYP2C9*2,*3 VKORC1 (−1639G>A) |
| eSensor Warfarin Sensitivity Test and XT-8 Instrument (Osmetech Molecular Diagnostics) | Warfarin | CYP450 2C9 *2,*3 VKORC1 (−1639G>A) |
| Gentris Rapid Genotyping Assay - CYP2C9 & VKORC1 (ParagonDx, LLC) | Warfarin | CYP2C9 *2 and *3 VKORC1 1173 C>T |
| INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin (AutoGenomics, Inc.) | Warfarin | CYP2C9*2,*3 VKORC1 (−1639G>A) |
| Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System (Nanosphere) | Warfarin | CYP2C9 *2 and *3 VKORC1 1173 C>T |
| THxID™ BRAF Kit (bioMérieux Inc.0 | Dabrafenib, Vemurafenib, Trametinib | BRAF V600E and V600K |
| cobas EGFR Mutation Test (Roche Molecular Systems, Inc.) | Erlotinib | exon 19 deletions and exon 21 (L858R) substitution mutations of the EGFR gene |
| VYSIS ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) | Crizotinib, Ceritinib | LSI TP53 probe target (17p-) |
| COBAS 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.) | Dabrafenib, Vemurafenib, Trametinib | BRAF V600E |
| VYSIS CLL FISH PROBE KIT (Abbott Molecular, Inc.) | Ibrutinib | 17p- |
| KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ARUP Laboratories, Inc.) | Imatinib | KIT D816V mutation |
| PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD) (ARUP Laboratories, Inc.) | Imatinib | 5q31~33 gene rearrangement |
| cobas® EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) | Erlotinib | Exon 19 deletions and L858R, G719X, exon 20 insertions, T790M, S768I and L861Q |
| therascreen® EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.) | Erlotinib | exon 19 deletions and exon 21 (L858R) |
| cobas® KRAS Mutation Test (Roche Molecular Systems, Inc.) | Cetuximab, Panitumumab | seven somatic mutations in codons 12 and 13 of the KRAS gene |
| BRACAnalysis CDx™ (Myriad Genetic Laboratories, Inc.) | Olaparib | variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes |
| therascreen KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.) | Cetuximab, Panitumumab | seven somatic mutations in the KRAS oncogene |
| therascreen EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.) | Erlotinib Afatinib |
exon 19 deletions and exon 21 (L858R) substitution mutations of the EGFR gene |
| INFORM HER-2/NEU (Ventana Medical Systems, Inc.) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |
| PATHVYSION HER-2 DNA Probe Kit (Abbott Molecular, Inc.) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |
| SPOT-LIGHT HER2 CISH Kit (Life Technologies, Inc.) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |
| HER2 CISH PharmDx Kit (Dako Denmark A/S) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |
| INFORM HER2 DUAL ISH DNA Probe Cocktail (Ventana Medical Systems, Inc.) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |
| HER2 FISH PharmDx Kit (Dako Denmark A/S) | Trastuzumab, Pertuzumab, Lapatinib, Everolimus | Her-2/Neu gene amplification |