List of Human Genetic Tests
Disease/Use | Trade Name | Manufacturer | Submission |
---|---|---|---|
Acute Myeloid Leukemia | Vysis D7S486/CEP 7 FISH Probe Kit | Abbott Molecular Inc. | K131508 |
Vysis EGR1 FISH Probe Kit | Abbott Molecular Inc. | K123951,K091960 | |
LeukoStrat CDx FLT3 Mutation Assay | INVIVOSCRIBE TECHNOLOGIES, INC | P160040 | |
Abbott RealTime IDH2 | ABBOTT MOLECULAR, INC. | P170005 | |
Abbott RealTime IDH1 | ABBOTT MOLECULAR, INC. | P170041 | |
Acute Myeloid Leukemia or Myelodysplastic Syndrome | VYSIS EGR1 FISH PROBE KIT – SC (SPECIMEN CHARACTERIZATION | ABBOTT MOLECULAR, INC. | DEN130010 |
Aggressive Systemic Mastocytosi | KIT D816V ASSAY | ARUP LABARATORIES | H140006 |
Autosomal Recessive Carrier Screening | 23ANDME PERSONAL GENOME SERVICE | 23andMe | DEN140044 |
B-cell chronic lymphocytic leukemia | VYSIS CLL FISH PROBE KIT | ABBOTT MOLECULAR, INC | K100015 |
VYSIS CLL FISH PROBE KIT | ABBOTT MOLECULAR, INC | P150041 | |
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe | Vysis | K962873 | |
Bladder Cancer | Vysis UroVysion Bladder Cancer Recurrence Kit | Vysis | K033982, K013785, K011031 |
Breast Cancer | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23andMe | DEN170046 |
Prosigna Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies | K130010 | |
MammaPrint | Agendia BV | K101454, K081092, K080252, K070675, K062694 | |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. | P100027 | |
HER2 CISH pharmDxTM Kit | Dako Denmark A/S | P100024 | |
GeneSearch Breast Lymph Node (BLN) Test Kit | Veridex, LLC. | P060017 S001-S004 | |
Dako TOP2A FISH PharmDx Kit | Dako Denmark A/S | P050045 S001-S004 | |
HER2 IQFISH PHARMDX | DAKO DENMARK A/S | P040005 | |
INSITE HER-2/NEU KIT | BIOGENEX LABORATORIES, INC. | P040030 | |
SPOT-LIGHT HER2 CISH KIT | INVITROGEN CORPORATION | P050040 | |
INFORM HER-2/NEU | VENTANA MEDICAL SYSTEMS, INC. | P940004 | |
DAKO HERCEPTEST | DAKO A/S | P980018 | |
PATH VYSION HER-2 DNA PROBE KIT | ABBOTT MOLECULAR, INC. | P980024 | |
DakoCytomation Her2 FISH pharmDx™ Kit | DakoCytomation Denmark A/S | P040005 | |
Therascreen PIK3CA RGQ PCR Kit | QIAGEN GMBH | P190001 | |
Therascreen PIK3CA RGQ PCR Kit | QIAGEN GMBH | P190004 | |
Chromosome abnormalities | Affymetrix CytoScan Dx Assay | Affymetrix, Inc. | K130313 |
AneuVysion | Vysis | K010288, K972200 | |
CYTOSCAN(R) DX | Affymetrix, Inc. | DEN130018 | |
GenetiSure Dx Postnatal Assay | Agilent Technologies, Inc. | K163367 | |
CEP 8 Spectrumorange DNA Probe Kit | Vysis | K953591 | |
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit | Vysis | K954214 | |
Chronic Myeloid Leukemia | Quantidex qPCR BCR-ABL IS Kit | ASURAGEN, INC. | DEN160003 |
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems | Cepheid | K190076 | |
QXDx BCR-ABL %IS Kit For Use On The QXDx AutoDG DdPCR System | Bio-Rad Laboratories, Inc. | K181661 | |
MRDx BCR-ABL Test, MRDx BCR-ABL Test Software | MolecularMD Corporation | K173492 | |
Coagulation Factors | Invader Factor V | Hologic, Inc. | K100980 |
Invader Factor II | Hologic, Inc. | K100943 | |
Illumina VeraCode Genotyping Test for Factor V and Factor II | Illumina, Inc. | K093129 | |
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping Test | Osmetech Molecular Diagnostics | K093974 | |
Xpert HemosIL FII & FV | Cepheid | K082118 | |
Verigene F5 Nucleic Acid Test Verigene F2 Nucleic Acid Test Verigene MTHFR Nucleic Acid Test | Nanosphere, Inc. | K070597 | |
INFINITI System | Autogenomics, Inc. | K060564 | |
Factor II (Prothrombin) G20210A Kit | Roche Diagnostics Corporation | K033612 | |
Factor V leiden Kit | Roche Diagnostics Corporation | K033607 | |
Invader MTHFR 677 | Hologic, Inc. | K100987 | |
Invader MTHFR 1298 | Hologic, Inc. | K100496 | |
COAGULATION, LATE-ONSET ALHEIMER’S DISEASE, PARKINSON’S DISEASE, CELIAC DISEASE, ALPHA-1 ANTITRYPSIN DEFICIENCY, EARLY-ONSET PRIMARY DYSTONIA, FACTOR IX DEFICIENCY, GAUCHER DISEASE TYPE 1, GLUCOSE-6-PHOPHATE DEHYDROGENASE DEFICIENCY, HERDITARY HEMOCHROMATOSIS, HEREDITARY THROMBOPHILIA | PERSONAL GENOME SERVICE (PGS) GENETIC HEALTH RISK TEST FOR HEREDITARY THROMBOPHILIA | 23andME | DEN160026 |
Colorectal Cancer | Cologuard | Exact Sciences Corporation | P130017 |
Therascreen KRAS RGQ PCR Kit | QIAGEN MANCHESTER LTD | P110027/P110030 | |
Epi ProColon® | Epigenomics AG | P130001 | |
Cobas KRAS MUTATION TEST | Roche Molecular Systems, Inc. | P140023 | |
Praxis Extended RAS Panel | Illumina, Inc. | P160038 | |
VENTANA ANTI-MLH-1(M1) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-PMS2 (A16-4) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH2 (G219-1129) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-MSH6 (SP 93) MOUSE MONOCLONAL PRIMARY ANTIBODY, VENTANA ANTI-BRAF V600E (VE1) MOUSE MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Systems | DEN170030 | |
Colorectal Cancer Predisposition | MUTYH-Associated Polyposis (MAP) | 23andMe | K182784 |
Cystic Fibrosis | Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay | Illumina, Inc | K132750 |
Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay | Illumina, Inc | K124006 | |
xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Luminex Molecular Diagnostics, Inc. | K163336 | |
xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | K163347 | |
eSensor CF Genotyping Test | Osmetech Molecular Diagnostics | K090901 | |
xTAG Cystic Fibrosis 60 Kit v2 | Luminex Molecular Diagnostics Inc. | K083845 | |
xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics Inc. | K083846 | |
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests | Nanosphere, Inc | K083294 | |
InPlex CF Molecular Test | Third Wave Technology, Inc. | K063787 | |
Cystic Fibrosis Genotyping Assay | Celera Diagnostics | K062028 | |
Tag-It Cystic Fibrosis Kit | Tm Bioscience Corporation | K060627, K043011 | |
eSensor Cystic Fibrosis Carrier Detection System | Clinical Micro Sensors, Inc. | K060543, K051435 | |
Drug Metabolizing enzymes | xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | K130189, K093420 |
xTAG CYP2D6 Kit v3 | Luminex Molecular Diagnostics, Inc. | K130189, K131565 | |
Spartan RX CYP2C19 Test System | Akonni Biosystems Inc. | K183530 | |
TruDiagnosis System | Akonni Biosystems Inc | K183530 | |
Verigene CYP2C 19 Nucleic Acid Test | Nanosphere, Inc. | K120466 | |
INFINITI CYP2C19 Assay | AutoGenomics, Inc. | K101683 | |
Invader UGT1A1 Molecular Assay | Third Wave Technologies Inc. | K051824 | |
Roche AmpliChip CYP450 microarray | Roche Molecular Systems, Inc. | K043576, K042259 | |
eSensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics | K110786 | |
eQ-PCR LC Warfarin Genotyping kit | TrimGen Corporation | K073071 | |
eSensor Warfarin Sensitivity Test and XT-8 Instrument | Osmetech Molecular Diagnostics | K073720 | |
Gentris Rapid Genotyping Assay – CYP2C9 & VKORCI | ParagonDx, LLC | K071867 | |
INFINITI 2C9 & VKORC1 Assay for Warfarin | AutoGenomics, Inc. | K073014 | |
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System | Nanosphere, Inc. | K070804 | |
Heart Transplant | AlloMap Molecular Expression Testing | xDx | K073482 |
Hematologic Malignancies | MLL (KMT2A) BREAKAPART FISH PROBE KIT; AML1 (RUNX1) BREAKAPART FISH PROBE KIT, P53 (TP53) DELETION FISH PROBE KIT; EVI1 (MECOM) BREAKAPART FISH PROBE KIT, DEL(20Q) DELETION FISH PROBE KIT; AML1/ETO (RUNX1/RUNXIT1)) TRANSLOCATION, DUAL FUSI, CBFB (CBFB) /MYH11 TRANSLOCATION, DUAL FUSION FISH PROBE KIT,DEL(5Q)DELETION FISH PROBE KIT; DEL(7Q)DELETION FISH PROBE KIT | CYTOCELL LTD | DEN170070 |
HEREDITARY THROMBOPHILIA | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST | SEQUENOM, INC./AGENA Bioscience | K132978 |
Melanoma | Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST | Roche Molecular Systems, Inc. | P110020 |
THXID-BRAF KIT | BioMerieux, Inc. | P120014 | |
Multiple Myeloma / Acute Lymphoblastic Leukemia (MRD) | ADAPTIVE BIOTECHNOLOGIES CLONOSEQ ASSAY | ADAPTIVE BIOTECHNOLOGIES CORPORATION | DEN170080 |
Myelodysplastic syndrome / myeloproliferative disease | Fluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangement | ARUP LABARATORIES | H140005 |
Myeloproliferative disease / Polycythemia Vera | Ipsogen JAK2 RGQ PCR Kit | QIAGEN INC | DEN160028 |
Myeloproliferative disease / Polycythemia Vera | Ipsogen JAK2 RGQ PCR Kit | QIAGEN INC | K172287 |
Non-Small Cell Lung Cancer | VYSIS ALK BREAK APART FISH PROBE KIT | ABBOTT MOLECULAR, INC. | P110012 |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P120019 | |
THERASCREEN EGFR RGQ PCR KIT | QIAGEN MANCHESTER LTD | P120022 | |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P150044 | |
Cobas EGFR MUTATION TEST v2 | Roche Molecular Systems, Inc. | P150047 | |
Oncomine Dx Target Test | LIFE TECHNOLOGIES CORPORATION | P160045 | |
Ovarian Cancer | BRACAnalysis CDx | Myriad Genetic Laboratories, Inc. | P140020 |
FoundationFocus CDxBRCA | FOUNDATION MEDICINE, INC | P160018 | |
Pharmacogenetic Reports | 23ANDME PERSONAL GENOME SERVICE (PGS) PHARMACOGENETIC REPORTS | 23andMe | DEN180028 |
Platforms, Imaging Systems, and Reagents | ILLUMINA MISEQDX PLATFORM | Illumina, Inc | DEN130011 |
MISEQDX UNIVERSAL KIT 1.0 | Illumina, Inc. | DEN130042 | |
DUET SYSTEM | BIOVIEW LTD. | K130775 | |
Prostate Cancer | NADiA ProsVue | Iris Molecular Diagnostics | K101185 |
PROGENSA PCA3 Assay | Gen-Probe, Inc. | P100033 | |
Severe Combined Immunodeficiency Disorder (SCID) | PerkinElmer Enlite TREC Test System | Wallac OY | DEN140010 |
Tissue of Origin | Pathwork Tissue of Origin Test Kit – FFPE | Pathwork Diagnostics Inc. | K120489, K092967 |
Pathwork Tissue of Origin Test | Pathwork Diagnostics Inc. | K080896 | |
Tissue of Origin Test Kit – FFPE | Cancer Genetics, Inc. | K173839 | |
Tumor Profiling | MSK-IMPACT (Integrated Mutation Profiling Of Actionable Cancer Targets):A Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center | DEN170058 |
FoundationOne CDx | Foundation Medicine, Inc. | P170019 | |
Tumor Profiling | Myriad myChoice CDx | Myriad Genetic Laboratories, Inc. | P190014 |
Tumor Profiling | Omics Core | NantHealth, Inc.. | K190661 |
Urothelial Cancer | Therascreen FGFR RGQ RT-PCR Kit | QIAGEN GmbH | P180043 |