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

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Companion Diagnostic Devices

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.

Related report: Global Companion Diagnostics for Oncology Market Research Report—Forecast till 2027

The use of an IVD companion diagnostic devices is stipulated in the instructions for use in the labeling of the diagnostic device, either including a specific therapeutic product(s) or, if approved for oncology products, a specific group of oncology therapeutic products (for information see the guidance for industry Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products). In addition, the use of an IVD companion diagnostic device is stipulated in the labeling of the 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 NamePMA/ 510(k)/ HDEDiagnostic ManufacturerIndication(s)
Trade Name (Generic) – NDA/BLA		Device Indication for a Specific Group of Oncology Therapeutic Products and Trade Name (Generic) – NDA/BLA
BRACAnalysis CDxP140020/S016
P140020/S019
P140020/S020		Myriad Genetic Laboratories, Inc.Breast Cancer

 

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

Ovarian Cancer

  • Lynparza (olaparib) – NDA 208558
  • Rubraca (rucaparib) – NDA 209115

Pancreatic Cancer

  • Lynparza (olaparib) – NDA 208558

Metastatic castrate resistant prostate cancer (mCRPC)

  • Lynparza (olaparib) – NDA 208558
 
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
P120019/S007
P120019/S016
P120019/S018
P120019/S019  P120019/S031		Roche Molecular Systems, Inc.Non-small cell lung cancer

 

  • EGFR exon 19 deletions
  • EGFR exon 21(L858R)

Tissue and Plasma

  • See next Column
Non-small cell lung cancer (tissue)

 

“identifying patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication”

List of tyrosine kinase inhibitors approved by FDA for this indication:

  • Tarceva (erlotinib) – NDA 021743
  • Tagrisso (osimertinib) – NDA 208065
  • Iressa (gefitinib) – NDA 206995
  • Gilotrif (afatinib)- NDA 201292
  • Vizimpro (dacomitinib)- NDA 211288

Non-small cell lung cancer (plasma)

“identifying patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and are suitable for treatment with a tyrosine kinase inhibitor approved by FDA for that indication”

List of tyrosine kinase inhibitors approved by FDA for this indication:

  • Tarceva (erlotinib) – NDA 021743
  • Tagrisso (osimertinib) – NDA 208065
  • Iressa (gefitinib) – NDA 206995
EGFR T790M
(Tissue and Plasma)

 

  • Tagrisso (osimertinib) – NDA 208065
 
PD-L1 IHC 22C3 pharmDxP150013
P150013/S006
P150013/S009
P150013/S011
P150013/S014
P150013/S016
P150013/S020
P150013/S021		Dako North America, Inc.Non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction adenocarcinoma, cervical cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), and esophageal squamous cell carcinoma (ESCC) and triple-negative breast cancer (TNBC)

 

  • KEYTRUDA (pembrolizumab) – BLA 125514
  • Libtayo (cemiplimab-rwlc) – BLA 761097
 
Abbott RealTime IDH1P170041Abbott Molecular, Inc.Acute myeloid leukemia

 

  • Tibsovo (ivosidenib) – NDA 211192
 
MRDx BCR-ABL TestK173492MolecularMD CorporationChronic myeloid leukemia

 

 
FoundationOne CDxP170019
P170019/S004
P170019/S006
P170019/S008
P170019/S011
P170019/S013
P170019/S015
P170019/S016
P170019/S017		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
  • Tabrecta (capmatinib) – NDA 213591

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
  • Piqray (alpelisib) – NDA 212526

Colorectal cancer

  • Erbitux (cetuximab) – BLA 125084
  • Vectibix (panitumumab) – BLA 125147

Ovarian cancer

  • Rubraca (rucaparib) – NDA 209115
  • Lynparza (olaparib) – NDA 208558

Cholangiocarcinoma

  • Pemazyre (pemigatinib) – NDA 213736

Metastatic castrate resistant prostate cancer (mCRPC)

  • Lynparza (olaparib) – NDA 208558

Solid tumors (TMB ≥ 10 mutations per megabase)

  • Keytruda (pembrolizumab) – BLA 125514

Solid tumors (NTRK1/2/3 fusions)

 
VENTANA ALK (D5F3) CDx AssayP140025/S006
P140025/S014		Ventana Medical Systems, Inc.Non-small cell lung cancer

 

  • Zykadia (ceritinib) – NDA 205755
  • Xalkori (crizotinib) – NDA 202570
  • Alecensa (alectinib) – NDA 208434
  • Lorbrena (lorlatinib) – NDA 210868
 
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 TestP160045
P160045/S019		Life Technologies CorporationNon-small cell lung cancer

 

  • Tafinlar (dabrafenib) in combination with Mekinist (trametinib) – NDA 202806 and NDA 204114
  • Xalkori (crizotinib) – NDA 202570
  • Iressa (gefitinib) – NDA 206995
  • Gavreto (pralsetinib) – NDA 213721
 
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/K124065Resonance Health Analysis Services Pty LtdNon-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-S028
P990081/S039		Ventana Medical Systems, Inc.Breast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
  • Kadcyla (ado-trastuzumab emtansine) – BLA 125427
 
InSite Her-2/neu KITP040030Biogenex Laboratories, Inc.Breast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
 
SPOT-LIGHT HER2 CISH KitP050040/S001-S003Life Technologies CorporationBreast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
 
Bond Oracle HER2 IHC SystemP090015Leica BiosystemsBreast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
 
HER2 CISH pharmDx KitP100024Dako Denmark A/SBreast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
 
INFORM HER2 Dual ISH DNA Probe CocktailP100027
P100027/S030		Ventana Medical Systems, Inc.Breast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
  • Kadcyla (ado-trastuzumab emtansine) – BLA 125427
 
HercepTestP980018/S018Dako Denmark A/SBreast 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
P040005/S005
P040005/S006
P040005/S009		Dako Denmark A/SBreast 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) – NDA 202806
 
Vysis ALK Break Apart FISH Probe KitP110012
P110012/S020		Abbott Molecular Inc.Non-small cell lung cancer (NSCLC)

 

  • Xalkori (crizotinib) – NDA 202570
  • Alunbrig (brigatinib) – NDA 208772
 
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
 
VENTANA PD-L1(SP142) AssayP160002/S006
P160002/S009
P160002/S012		Ventana Medical Systems, Inc.Urothelial carcinoma, Triple-Negative Breast Carcinoma (TNBC) and Non-small cell lung cancer (NSCLC)

 

  • TECENTRIQ (atezolizumab) – BLA 761034
 
therascreen FGFR RGQ RT-PCR KitP180043QIAGEN Manchester Ltd.urothelial cancer

 

  • BALVERSA (erdafitinib) – NDA 212018
 
therascreen PIK3CA RGQ PCR KitP190001
P190004		QIAGEN GmbHBreast cancer (tissue and plasma)

 

  • PIQRAY (alpelisib) – NDA 212526
 
Myriad myChoice® CDxP190014
P190014/S003		Myriad Genetic Laboratories, Inc.Ovarian Cancer

 

  • Zejula® (niraparib) – NDA 208447
  • Lynparza (olaparib) – NDA 208558
 
therascreen BRAF V600E RGQ PCR KitP190026QIAGEN GmbHColorectal Cancer

 

  • BRAFTOVI (encorafenib) – NDA 210496 in combination with Erbitux (cetuximab) – BLA 125084
 
PD-L1 IHC 28-8 pharmDxP150025/S013Dako North America, Inc.Non-small cell lung cancer (NSCLC)

 

  • OPDIVO (nivolumab) (BLA 125554) in combination with YERVOY (ipilimumab) (BLA 125377)
 
cobas EZH2 Mutation TestP200014Roche Molecular Systems, Inc.Follicular lymphoma tumor

 

  • Tazverik (tazemetostat) – NDA 213400
 
VENTANA HER2 Dual ISH DNA Probe CocktailP190031Ventana Medical Systems, Inc.Breast cancer

 

  • Herceptin (trastuzumab) – BLA 103792
 
Guardant360® CDxP200010Guardant Health, Inc.Non-small cell lung cancer (plasma)

 

  • Tagrisso (osimertinib) – NDA 208065
 
FoundationOne® Liquid CDxP190032
P200006
P200016		Foundation Medicine, Inc.Non-small cell lung cancer (plasma)

 

  • Iressa (gefitinib) – NDA 206995
  • Tagrisso (osimertinib) – NDA 208065
  • Tarceva (erlotinib) – NDA 021743
  • Alecensa (alectinib) – NDA 208434

Metastatic castrate resistant prostate cancer (mCRPC) (plasma)

Ovarian cancer (plasma)

  • Rubraca (rucaparib) – NDA 209115

Breast cancer (plasma)

  • Piqray (alpelisib) – NDA 212526
 
VENTANA MMR RxDx PanelP200019Ventana Medical Systems, Inc.Endometrial Carcinoma (EC)

 

  • Jemperli (dostarlimab-gxly) – BLA 761174
 

Source: FDA

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