A companion diagnostic device can be In Vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a specific therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
For FDA cleared or approved nucleic acid-based tests, see Nucleic Acid-Based Tests.
This table lists devices in the order of approval, with the most recently approved device at the top.
Diagnostic NamePMA/510(k)/ HDEDiagnostic ManufacturerTrade Name (Generic) - NDA/BLABRACAnalysis CDxP140020/S016Myriad Genetic Laboratories, Inc.
Breast Cancer
Lynparza (olaparib) – NDA 208558
Talzenna (talazoparib) – NDA 211651
Ovarian Cancer
Lynparza (olaparib) – NDA 208558
Rubraca (rucaparib) – NDA209115therascreen EGFR RGQ PCR KitP120022/S018Qiagen Manchester, Ltd.
Non-small Cell Lung Cancer
Iressa (gefitinib) – NDA 206995
Gilotrif (afatinib)- NDA 201292
Vizimpro (dacomitinib)- NDA211288cobas EGFR Mutation Test v2P120019/S019Roche Molecular Systems, Inc.
Non-small Cell Lung Cancer (Tissue and Plasma)
Tarceva (erlotinib) – NDA 021743
Tagrisso (osimertinib) – NDA 208065
Iressa (gefitinib) – NDA206995PD-L1 IHC 22C3 pharmDxP150013/S011Dako North America, Inc.
Non-small Cell Lung Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, and Urothelial Carcinoma
Keytruda (pembrolizimab) – BLA 125514
VENTANA PD-L1(SP142) AssayP160002/S006Ventana Medical Systems, Inc.
Non-small Cell Lung Cancer and Urothelial Carcinoma
Tecentriq (atezolizumab) – sBLA 761034/S012
Abbott RealTimeIDH1P170041Abbott Molecular, Inc.
Acute Myeloid leukemia
Tibsovo (ivosidenib) – NDA 211192
MRDx BCR-ABL TestK173492MolecularMD Corporation
Chronic Myeloid Leukemia
Tasigna (nilotinib) – NDA 022068/S026
FoundationOne CDxP170019Foundation Medicine, Inc.
Non-small cell lung cancer
Gilotrif (afatinib) – NDA 201292
Iressa (gefitinib) – NDA 206995
Tarceva (erlotinib) – NDA 021743
Tagrisso (osimertinib) NDA 208065
Alecensa (alectinib) – NDA 208434
Xalkori (crizotinib) – NDA 202570
Zykadia (ceritinib) – NDA 205755
Tafinlar (dabrafenib) – NDA 202806 in combination with Mekinist (trametinib) – NDA 204114
Melanoma
Tafinlar (dabrafenib) – NDA 202806
Zelboraf (vemurafenib) – NDA 202429
Mekinist (trametinib) – NDA 204114 or
Cotellic (cobimetinib) – NDA 206192 in combination with Zelboraf (vemurafenib) – NDA 202429
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
Perjeta (pertuzumab) – BLA 125409
Kadcyla (ado-trastuzumab emtansine) – BLA 125427
Colorectal Cancer
Erbitux (cetuximab) – BLA 125084
Vectibix (panitumumab) – BLA 125147
Ovarian Cancer
Rubraca (rucaparib) – NDA 209115
VENTANA ALK (D5F3) CDx AssayP140025/S006Ventana Medical Systems, Inc.
Non-small Cell Lung Cancer
Zykadia (ceritinib) – NDA 205755
Xalkori (crizotinib) – NDA 202570
Alecensa (alectinib) – NDA 208434
Abbott RealTime IDH2P170005Abbott Molecular, Inc.
Acute Myeloid Leukemia
Idhifa (enasidenib) – NDA 209606
Praxis Extended RAS PanelP160038Illumina, Inc.
Colorectal Cancer
Vectibix (panitumumab) – NDA 125147
Oncomine Dx Target TestP160045Life Technologies Corporation
Non-small Cell Lung Cancer
Tafinlar (dabrafenib) – NDA 202806
Mekinist (trametinib) – NDA 204114
Xalkori (crizotinib) – NDA 202570
Iressa (gefitinib) – NDA 206995
LeukoStrat CDx FLT3 Mutation AssayP160040Invivoscribe Technologies, Inc.
Acute Myelogenous Leukemia
Rydapt (midostaurin) – NDA 207997
Xospata (gilterinib) – NDA 211349
FoundationFocus CDxBRCAAssayP160018Foundation Medicine, Inc.
Ovarian cancer
Rubraca (rucaparib) – NDA 209115
Vysis CLL FISH Probe KitP150041Abbott Molecular, Inc.
B-Cell Chronic Lymphocytic Leukemia
Venclexta (venetoclax) – NDA 208573
KIT
D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)
H140006ARUP Laboratories, Inc.
Aggressive Systemic Mastocytosis
Gleevec (imatinib mesylate) – NDA 021335
PDGFRB
FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS/MPD)
H140005ARUP Laboratories, Inc.
Myelodysplastic Syndrome/Myeloproliferative Disease
Gleevec (imatinib mesylate) – NDA 021335
cobas KRAS Mutation TestP140023Roche Molecular Systems, Inc.
Colorectal Cancer
Erbitux (cetuximab) – BLA 125084
Vectibix (panitumumab) – BLA 125147
therascreen KRAS RGQ PCR KitP110030P110027Qiagen Manchester, Ltd.
Colorectal Cancer
Erbitux (cetuximab) – BLA 125084
Vectibix (panitumumab) – BLA 125147
Dako EGFR pharmDx KitP030044/S002Dako North America, Inc.
Colorectal Cancer
Erbitux (cetuximab) – BLA 125084
Vectibix (panitumumab) – BLA125147FerriScanDEN130012/K124065Resonance Health Analysis Services Pty Ltd
Non-Transfusion-Dependent Thalassemia
Exjade (deferasirox) – NDA 021882
Dako c-KIT pharmDxP040011Dako North America, Inc.
Gastrointestinal Stromal Tumors
Gleevec (imatinib mesylate) – NDA 021335
Glivec (imatinib mesylate) – NDA 021588
INFORM HER-2/neuP940004Ventana Medical Systems, Inc.
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
PathVysion HER-2 DNA Probe KitP980024Abbott Molecular Inc.
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary AntibodyP990081/S001-S028Ventana Medical Systems, Inc.
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
InSite Her-2/neu KITP040030Biogenex Laboratories, Inc.
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
SPOT-LIGHT HER2 CISH KitP050040/S001-S003Life Technologies Corporation
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
Bond Oracle HER2 IHC SystemP090015Leica Biosystems
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
HER2 CISH pharmDx KitP100024Dako Denmark A/S
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
INFORM HER2 Dual ISH DNA Probe CocktailP100027Ventana Medical Systems, Inc.
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
HercepTestP980018/S018Dako Denmark A/S
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
Perjeta (pertuzumab) – BLA 125409
Kadcyla (ado-trastuzumab emtansine) – BLA 125427
Gastric and Gastroesophogeal Cancer
Herceptin (trastuzumab) – BLA 103792
HER2 FISH pharmDx KitP040005/S009Dako Denmark A/S
Breast Cancer
Herceptin (trastuzumab) – BLA 103792
Perjeta (pertuzumab) – BLA 125409
Kadcyla (ado-trastuzumab emtansine) – BLA 125427
Gastric and Gastroesophogeal Cancer
Herceptin (trastuzumab) – BLA 103792
THXID BRAF KitP120014bioMérieux Inc.
Melanoma
Braftovi (encorafenib) in combination with Mektovi (binimetinib) – NDA 210496 and NDA 210498
Mekinist (tramatenib) – NDA 204114
Tafinlar (dabrafenib) – NDA202806Vysis ALK Break Apart FISH Probe KitP110012Abbott Molecular Inc.
Non-Small Cell Lung Cancer
Xalkori (crizotinib) – NDA 202570
cobas 4800 BRAF V600 Mutation TestP110020/S016Roche Molecular Systems, Inc.
Melanoma
Zelboraf (vemurafenib) – NDA 202429
Cotellic (cobimetinib) – NDA206192in combination with Zelboraf (vemurafenib) – NDA202429VENTANA PD-L1(SP142) AssayP160002/S009Ventana Medical Systems, Inc.
Triple-Negative Breast Carcinoma (TNBC), Non-small Cell Lung Cancer and Urothelial Carcinoma
Tecentriq (atezolizumab) – sBLA 761034/S012
therascreen
FGFR RGQ RT-PCR Kit
P180043QIAGEN Manchester Ltd.
Urothelial Cancer
BALVERSA (erdafitinib) – NDA 212018
therascreen
PIK3CA RGQ PCR Kit
P190001P190004QIAGEN GmbH
Breast Cancer (Tissue and Plasma)
PIQRAY (alpelisib) – NDA 212526