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 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.
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| Diagnostic Name | PMA/ 510(k)/ HDE | Diagnostic Manufacturer | Indication(s) Trade Name (Generic) - NDA/BLA |
Device Indication for a Specific Group of Oncology Therapeutic Products and Trade Name (Generic) – NDA/BLA |
|---|---|---|---|---|
| BRACAnalysis CDx | Myriad Genetic Laboratories, Inc. |
Breast Cancer Ovarian Cancer Pancreatic Cancer
Metastatic castrate resistant prostate cancer (mCRPC)
|
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| therascreen EGFR RGQ PCR Kit | P120022/S018 | Qiagen Manchester, Ltd. |
Non-small cell lung cancer |
|
| cobas EGFR Mutation Test v2 | P120019 P120019/S007 P120019/S016 P120019/S018 P120019/S019 P120019/S031 |
Roche Molecular Systems, Inc. |
Non-small cell lung cancer
Tissue and Plasma
|
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:
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: |
|
EGFR T790M
|
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| PD-L1 IHC 22C3 pharmDx |
P150013 |
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) |
|
| Abbott RealTime IDH1 | P170041 | Abbott Molecular, Inc. |
Acute myeloid leukemia
|
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| MRDx BCR-ABL Test | K173492 | MolecularMD Corporation |
Chronic myeloid leukemia
|
|
| FoundationOne CDx |
P170019 |
Foundation Medicine, Inc. |
Non-small cell lung cancer
Breast cancer
Colorectal cancer Ovarian cancer Cholangiocarcinoma Metastatic castrate resistant prostate cancer (mCRPC)
Solid tumors (TMB ≥ 10 mutations per megabase)
Solid tumors (NTRK1/2/3 fusions) |
|
|
Melanoma (BRAF V600E and V600K)
See next column for group labeling indications |
Melanoma List of BRAF Inhibitors approved by FDA for this indication: “identifying patients with melanoma whose tumors have BRAF V600E and V600K and are suitable for treatment with BRAF/MEK Inhibitor Combinations approved by FDA for that indication” List of BRAF/MEK Inhibitor Combinations approved by FDA for this indication: |
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| VENTANA ALK (D5F3) CDx Assay | Ventana Medical Systems, Inc. |
Non-small cell lung cancer
|
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| Abbott RealTime IDH2 | P170005 | Abbott Molecular, Inc. |
Acute myeloid leukemia
|
|
| Praxis Extended RAS Panel | P160038 | Illumina, Inc. |
Colorectal cancer
|
|
| Oncomine Dx Target Test | P160045 P160045/S019 P160045/S028 P160045/S029 |
Life Technologies Corporation |
Non-small cell lung cancer |
|
| LeukoStrat CDx FLT3 Mutation Assay | P160040 | Invivoscribe Technologies, Inc. |
Acute myelogenous leukemia |
|
| FoundationFocus CDxBRCA Assay | P160018 | Foundation Medicine, Inc. |
Ovarian cancer
|
|
| Vysis CLL FISH Probe Kit | P150041 | Abbott Molecular, Inc. |
B-cell chronic lymphocytic leukemia
|
|
| KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) | H140006 | ARUP Laboratories, Inc. |
Aggressive systemic mastocytosis
|
|
| PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS/MPD) | H140005 | ARUP Laboratories, Inc. |
Myelodysplastic syndrome/myeloproliferative disease
|
|
| cobas KRAS Mutation Test | P140023 | Roche Molecular Systems, Inc. |
Colorectal cancer |
|
| therascreen KRAS RGQ PCR Kit | P110030 P110027 P110027/S012 |
Qiagen Manchester, Ltd. |
Colorectal cancer Non-Small Cell Lung Cancer (NSCLC)
|
|
| Dako EGFR pharmDx Kit | P030044/S002 | Dako North America, Inc. |
Colorectal cancer |
|
| FerriScan | DEN130012/K124065 |
Resonance Health Analysis Services Pty Ltd |
Non-transfusion-dependent thalassemia
|
|
| Dako c-KIT pharmDx | P040011 | Dako North America, Inc. |
Gastrointestinal stromal tumors |
|
| INFORM HER-2/neu | P940004 | Ventana Medical Systems, Inc. |
Breast cancer
|
|
| PathVysion HER-2 DNA Probe Kit | P980024 | Abbott Molecular Inc. |
Breast cancer
|
|
| PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody | P990081/S001-S028 P990081/S039 |
Ventana Medical Systems, Inc. |
Breast cancer |
|
| InSite Her-2/neu KIT | P040030 | Biogenex Laboratories, Inc. |
Breast cancer
|
|
| SPOT-LIGHT HER2 CISH Kit | P050040/S001-S003 | Life Technologies Corporation |
Breast cancer
|
|
| Bond Oracle HER2 IHC System | P090015 | Leica Biosystems |
Breast cancer
|
|
| HER2 CISH pharmDx Kit | P100024 | Dako Denmark A/S |
Breast cancer
|
|
| INFORM HER2 Dual ISH DNA Probe Cocktail | P100027 P100027/S030 |
Ventana Medical Systems, Inc. |
Breast cancer |
|
| HercepTest | P980018/S018 | Dako Denmark A/S |
Breast cancer
Gastric and gastroesophogeal cancer
|
|
| HER2 FISH pharmDx Kit | P040005 P040005/S005 P040005/S006 P040005/S009 |
Dako Denmark A/S |
Breast cancer
Gastric and gastroesophogeal cancer
|
|
| THXID BRAF Kit | P120014 | bioMérieux Inc. |
Melanoma |
|
| Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular Inc. |
Non-small cell lung cancer (NSCLC) |
||
| cobas 4800 BRAF V600 Mutation Test | P110020/S016 | Roche Molecular Systems, Inc. |
Melanoma |
|
| VENTANA PD-L1(SP142) Assay | P160002/S006 P160002/S009 |
Ventana Medical Systems, Inc. |
Urothelial carcinoma and Non-small cell lung cancer (NSCLC)
|
|
| therascreen FGFR RGQ RT-PCR Kit | P180043 | QIAGEN Manchester Ltd. | urothelial cancer
|
|
| therascreen PIK3CA RGQ PCR Kit | P190001 P190004 |
QIAGEN GmbH | Breast cancer (tissue and plasma)
|
|
| Myriad myChoice® CDx | P190014 P190014/S003 |
Myriad Genetic Laboratories, Inc. | Ovarian Cancer | |
| therascreen BRAF V600E RGQ PCR Kit | P190026 | QIAGEN GmbH | Colorectal Cancer | |
| PD-L1 IHC 28-8 pharmDx | P150025/S013 | Dako North America, Inc. |
Non-small cell lung cancer (NSCLC) |
|
|
cobas EZH2 Mutation Test |
Roche Molecular Systems, Inc. |
Follicular lymphoma tumor
|
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| VENTANA HER2 Dual ISH DNA Probe Cocktail | P190031 | Ventana Medical Systems, Inc. |
Breast cancer
|
|
| Guardant360® CDx | Guardant Health, Inc. |
Non-small cell lung cancer (plasma) |
||
| FoundationOne® Liquid CDx | Foundation Medicine, Inc. |
Non-small cell lung cancer (plasma)
Metastatic castrate resistant prostate cancer (mCRPC) (plasma) Ovarian cancer (plasma)
Breast cancer (plasma)
|
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| VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. |
Endometrial Carcinoma (EC)
Mismatch repair deficient (dMMR) Solid tumors
|
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| ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) | P200011 | Pillar Biosciences, Inc. |
Colorectal Cancer (CRC) Non-Small Cell Lung Cancer (NSCLC) |
|
| VENTANA PD-LI (SP263) Assay | P160046/S010 | Ventana Medical Systems, Inc | Non-small cell lung cancer (NSCLC)
|
|
| Ki-67 IHC MIB-1 pharmDx (Dako Omnis) | P210026 | Agilent Technologies | Breast Cancer
Verzenio (abemaciclib) - NDA 208716 |