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.

Download a Printable Version of this Table

Diagnostic NamePMA/ 510(k)/ HDEDiagnostic ManufacturerTrade Name (Generic) - NDA/BLA
BRACAnalysis CDxP140020/S016Myriad 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 KitP120022/S018Qiagen Manchester, Ltd.

Non-small cell lung cancer

  • Iressa (gefitinib) - NDA 206995
  • Gilotrif (afatinib)- NDA 201292
  • Vizimpro (dacomitinib)- NDA 211288
cobas 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) - NDA 206995
PD-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
PD-L1 (SP142)P160002/S006Ventana Medical Systems, Inc.

Non-small cell lung cancer and urothelial carcinoma

Abbott RealTime IDH1P170041Abbott Molecular, Inc.

Acute myeloid leukemia

  • Tibsovo (ivosidenib) - NDA 211192
MRDx BCR-ABL TestK173492MolecularMD Corporation

Chronic myeloid leukemia

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 Assay P140025/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 CDxBRCA AssayP160018Foundation 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 KitP110030
P110027
Qiagen 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) - BLA 125147
FerriScanDEN130012/K124065
 
Resonance 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

Gastic 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

Gastic 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) - NDA 202806
Vysis ALK Break Apart FISH Probe KitP110012Abbott Molecular Inc.

Non-small cell lung cancer

cobas 4800 BRAF V600 Mutation TestP110020/S016Roche Molecular Systems, Inc.

Melanoma

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

 

Page Last Updated: 12/13/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English