FDA, DIAGNOSTIC, COMPANION DIAGNOSTICS, MOLECULAR DIAGNOSTICS RECUITERS, COMPANION DIAGNOSTICS RECRUITER
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 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 |
| VENTANA PD-L1(SP142) Assay | P160002/S006 | Ventana Medical Systems, Inc. |
Non-small Cell Lung Cancer and Urothelial Carcinoma Tecentriq (atezolizumab) – sBLA 761034/S012 |
| Abbott RealTime IDH1 | P170041 | Abbott Molecular, Inc. |
Acute Myeloid leukemia Tibsovo (ivosidenib) – NDA 211192 |
| MRDx BCR-ABL Test | K173492 | MolecularMD Corporation |
Chronic Myeloid Leukemia Tasigna (nilotinib) – NDA 022068/S026 |
| 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 Xospata (gilterinib) – NDA 211349 |
| 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 |
| therascreen KRAS RGQ PCR Kit | P110030 P110027 | Qiagen Manchester, Ltd. |
Colorectal Cancer Erbitux (cetuximab) – BLA 125084 |
| 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 Gastric 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 Gastric and Gastroesophogeal Cancer Herceptin (trastuzumab) – BLA 103792 |
| THXID BRAF Kit | P120014 | bioMérieux 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 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 |
| VENTANA PD-L1(SP142) Assay | P160002/S009 | Ventana 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 |
P180043 | QIAGEN Manchester Ltd. |
Urothelial Cancer BALVERSA (erdafitinib) – NDA 212018 |
|
therascreen PIK3CA RGQ PCR Kit |
P190001 P190004 | QIAGEN GmbH |
Breast Cancer (Tissue and Plasma) PIQRAY (alpelisib) – NDA 212526 |
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