Table 1.
FDA-approved rabbit pAbs and mAbs for diagnostic applications.1
| Antibody | Manufacturer | Assay2 | Antigen | Diagnostic application | FDA approval |
|---|---|---|---|---|---|
| rabbit pAb | PCL-RIA | RIA | human thyroid stimulating hormone | measurement of thyroid stimulating hormone concentration in blood | 1978 |
| rabbit pAb | PCL-RIA | RIA | digoxin | measurement of digoxin concentration in blood | 1978 |
| rabbit pAb | PCL-RIA | RIA | Human triiodothyronine | measurement of triiodothyronine concentration in blood | 1978 |
| rabbit pAb | Dako | ELISA and IHC | human Ig light chain | measurement of free Ig light chain in blood and tissues | 1995 |
| rabbit mAb | Ventana | IHC | human HER2 | companion diagnostic for anti-HER2 mAb (trastuzumab) therapy of breast cancer | 2000 |
| rabbit pAb | Dako | IHC | human CD117 | companion diagnostic for imatinib mesylate therapy of gastrointestinal stromal tumor | 2005 |
| rabbit mAb | Lab Vision | IHC | human progesterone receptor | companion diagnostic for hormone therapy of breast cancer | 2006 |
| rabbit mAb | Lab Vision | IHC | human estrogen receptor | companion diagnostic for hormone therapy of breast cancer | 2006 |
| rabbit mAb | Dako | IHC | human estrogen receptor | companion diagnostic for hormone therapy of breast cancer | 2009 |
| rabbit mAb | Ventana | IHC | Helicobacter pylori | detection of Helicobacter pylori infection | 2011 |
| rabbit mAb | Ventana | IHC | human progesterone receptor | companion diagnostic for hormone therapy of breast cancer | 2011 |
| rabbit mAb | Ventana | IHC | human estrogen receptor | companion diagnostic for hormone therapy of breast cancer | 2012 |
| rabbit mAb | Dako | IHC | human PD-L1 | companion diagnostic for anti-PD1 mAb (nivolumab) therapy of lung cancer and melanoma | 2015, 2016 |
| rabbit mAb | Ventana | IHC | human PD-L1 | companion diagnostic for anti-PD-L1 mAb (atezolizumab and durvalumab) therapy of bladder and lung cancer | 2016, 2017 |
1
Based on a search (“rabbit antibody”) of Devices@FDA via www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm on June 13, 2018.
2
Abbreviations: RIA, radioimmunoassay; ELISA, enzyme-linked immunosorbant assay; IHC, immunohistochemistry