Table 3.
A list of FDA approved rabbit mAbs that are used in diagnostics.
| Device Name | FDA Approval Year | Company | Target | Diagnosis | |
|---|---|---|---|---|---|
| 1. | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor A, Clone EPI, RTU (Dako Onmis) | 2017 | DAKO DENMARK | Anti-Human Estrogen Receptor α | human breast carcinomas |
| 2. | VENTANA PD-L1 (SP263) ASSAY | 2017 | Ventana Medical Systems, Inc. | anti- Programmed Death-Ligand 1 (PD-L1) | in the assessment of the PD-L1 protein urothelial carcinoma tissue |
| 3. | VENTANA PD-L1 (SP142) Assay | 2016 | Ventana Medical Systems, Inc. | anti- Programmed Death-Ligand 1 (PD-L1) | in the assessment of the PD-L1 protein urothelial carcinoma and non-small cell lung cancer (NSCLC) tissue |
| 4. | VENTANA PD-L1(SP142) CDX ASSAY | 2016 | Ventana Medical Systems, Inc. | anti- Programmed Death-Ligand 1 (PD-L1) | in the assessment of the PD-L1 protein urothelial carcinoma tissue |
| 5. | PD-L1 IHC 28-8 PharmDx | 2016 | Dakoako North America Inc. | anti- Programmed Death-Ligand 1 (PD-L1) | in the assessment of the PD-L1 protein non- squamous non-small cell lung cancer (NSCLC) tissue and melanoma tissue |
| 6. | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | 2013 | Dako North America Inc. | Human Estrogen Receptor α | human breast carcinomas |
| 7. | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | 2012 | Ventana Medical Systems, Inc | Anti-Human Estrogen Receptor α | human breast carcinomas |
| 8. | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | 2011 | Ventana Medical Systems, Inc | Anti-Progesterone receptor | prognosis, and prediction of hormone therapy for breast carcinoma |
| 9. | VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY | 2011 | Ventana Medical Systems, Inc | anti-Helicobacter pyloni | in vitro diagnostic against H-. pylori organisms |
| 10. | MONOCLONAL RABBIT ANTI HUMAN ESTROGEN RECEPTOR ALPHA ANTIBODY CLONE SP1, MODEL M3634 | 2009 | Dako North America Inc. | Anti-Human Estrogen Receptor | Identification of estrogen receptor (ER) expression in normal and neoplastic tissues |
| 11. | VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT PRIMARY ANTIBODY | 2004 | Ventana Medical Systems, Inc | Anti-c-KIT | Gastrointestinal stromal tumors |
| 12. | PATHWAY ANTI-HCR-2/NCU RABBIT MONOCLONAL PRIMARY ANTIBODY | 2000 | Ventana Medical Systems, Inc | ANTI-HCR-2/NCU | Assessment of Breast cancer patients for whom HERCEPTIN(R) treatment is being considered |