Medical Devices

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)

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 most recently approved device at the top.

Diagnostic Name PMA/ 510(k)/ HDE Diagnostic Manufacturer Trade Name (Generic) - NDA/BLA
BRACAnalysis CDx P140020/S016 Myriad Genetic Laboratories, Inc.

Breast Cancer

  • Lynparza (olaparib) - NDA 208558
  • Talzenna (talazoparib) – NDA 211651

Ovarian Cancer

  • Lynparza (olaparib) - NDA 208558
  • Rubraca (rucaparib) – NDA 209115
therascreen EGFR RGQ PCR Kit P120022/S018 Qiagen Manchester, Ltd.

Non-small cell lung cancer

  • Iressa (gefitinib) - NDA 206995
  • Gilotrif (afatinib)- NDA 201292
  • Vizimpro (dacomitinib)- NDA 211288
cobas EGFR Mutation Test v2 P120019/S019 Roche Molecular Systems, Inc.

Non-small cell lung cancer (tissue and plasma)

  • Tarceva (erlotinib) - NDA 021743
  • Tagrisso (osimertinib) - NDA 208065
  • Iressa (gefitinib) - NDA 206995
PD-L1 IHC 22C3 pharmDx P150013/S011 Dako North America, Inc.

Non-small cell lung cancer, gastric or gastroesophageal junction adenocarcinoma, cervical cancer, and urothelial carcinoma

  • Keytruda (pembrolizimab) - BLA 125514
PD-L1 (SP142) P160002/S006 Ventana Medical Systems, Inc.

Non-small cell lung cancer and urothelial carcinoma

Abbott RealTime IDH1 P170041 Abbott Molecular, Inc.

Acute myeloid leukemia

  • Tibsovo (ivosidenib) - NDA 211192
MRDx BCR-ABL Test K173492 MolecularMD Corporation

Chronic myeloid leukemia

FoundationOne CDx P170019 Foundation 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 Assay  P140025/S006 Ventana Medical Systems, Inc.

Non-small cell lung cancer

  • Zykadia (ceritinib) - NDA 205755
  • Xalkori (crizotinib) - NDA 202570
  • Alecensa (alectinib) - NDA 208434
Abbott RealTime IDH2 P170005 Abbott Molecular, Inc.

Acute myeloid leukemia

  • Idhifa (enasidenib) – NDA 209606
Praxis Extended RAS Panel P160038 Illumina, Inc.

Colorectal cancer

  • Vectibix (panitumumab) – NDA 125147
Oncomine Dx Target Test P160045 Life 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 Assay P160040 Invivoscribe Technologies, Inc.

Acute myelogenous leukemia

  • Rydapt (midostaurin) – NDA 207997
FoundationFocus CDxBRCA Assay P160018 Foundation Medicine, Inc.

Ovarian cancer

  • Rubraca (rucaparib) – NDA 209115
Vysis CLL FISH Probe Kit P150041 Abbott 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) H140006 ARUP Laboratories, Inc.

Aggressive systemic mastocytosis

  • Gleevec (imatinib mesylate) – NDA 021335
PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS/MPD) H140005 ARUP Laboratories, Inc.

Myelodysplastic syndrome/myeloproliferative disease

  • Gleevec (imatinib mesylate) – NDA 021335
cobas KRAS Mutation Test P140023 Roche Molecular Systems, Inc.

Colorectal cancer

  • Erbitux (cetuximab) - BLA 125084
  • Vectibix (panitumumab) - BLA 125147
therascreen KRAS RGQ PCR Kit P110030
P110027
Qiagen Manchester, Ltd.

Colorectal cancer

  • Erbitux (cetuximab) - BLA 125084
  • Vectibix (panitumumab) - BLA 125147
Dako EGFR pharmDx Kit P030044/S002 Dako North America, Inc.

Colorectal cancer

  • Erbitux (cetuximab) - BLA 125084
  • Vectibix (panitumumab) - BLA 125147
FerriScan DEN130012/K124065
 
Resonance Health Analysis Services Pty Ltd

Non-transfusion-dependent thalassemia

  • Exjade (deferasirox) – NDA 021882
Dako c-KIT pharmDx P040011 Dako North America, Inc.

Gastrointestinal stromal tumors

  • Gleevec (imatinib mesylate) – NDA 021335
  • Glivec (imatinib mesylate) – NDA 021588
INFORM HER-2/neu P940004 Ventana Medical Systems, Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
PathVysion HER-2 DNA Probe Kit P980024 Abbott Molecular Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody P990081/S001-S028 Ventana Medical Systems, Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
InSite Her-2/neu KIT P040030 Biogenex Laboratories, Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
SPOT-LIGHT HER2 CISH Kit P050040/S001-S003 Life Technologies Corporation

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
Bond Oracle HER2 IHC System P090015 Leica Biosystems

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
HER2 CISH pharmDx Kit P100024 Dako Denmark A/S

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
INFORM HER2 Dual ISH DNA Probe Cocktail P100027 Ventana Medical Systems, Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
HercepTest P980018/S018 Dako Denmark A/S

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
  • Perjeta (pertuzumab) - BLA 125409
  • Kadcyla (ado-trastuzumab emtansine) - BLA 125427

Gastic and gastroesophogeal cancer

  • Herceptin (trastuzumab) - BLA 103792
HER2 FISH pharmDx Kit P040005/S009 Dako Denmark A/S

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
  • Perjeta (pertuzumab) - BLA 125409
  • Kadcyla (ado-trastuzumab emtansine) - BLA 125427

Gastic and gastroesophogeal cancer

  • Herceptin (trastuzumab) - BLA 103792
THXID BRAF Kit P120014 bioMérieux Inc.

Breast cancer

  • Herceptin (trastuzumab) - BLA 103792
  • Mekinist (tramatenib) - NDA 204114
  • Tafinlar (dabrafenib) – NDA 202806
Vysis ALK Break Apart FISH Probe Kit P110012 Abbott Molecular Inc.

Non-small cell lung cancer

  • Xalkori (crizotinib) – NDA 202570
cobas 4800 BRAF V600 Mutation Test P110020/S016 Roche Molecular Systems, Inc.

Melanoma

  • Zelboraf (vemurafenib) - NDA 202429
  • Cotellic (cobimetinib) - NDA 206192 in combination with Zelboraf (vemurafenib) - NDA 202429

Page Last Updated: 10/24/2018
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