Table 3.
FDA approved companion diagnostics assays for HER2 targeted drugs. Not all the listed assays are currently available from the diagnostic manufactures (51).
| Assay | Manufacturer | Breast cancer | Gastric cancer |
|---|---|---|---|
| IHC Assays | |||
| Bond Oracle HER2 IHC System | Leica Biosystems | Trastuzumab | |
| HercepTest™ | Agilent Technologies/Dako Denmark | Trastuzumab | Trastuzumab |
| Pertuzumab | |||
| Ado-trastuzumab emtansine | |||
| InSite™ Her-2/neu KIT | Biogenex Laboratories | Trastuzumab | |
| PATHWAY anti-Her2/neu | Ventana Medical Systems | Trastuzumab | |
| Ado-trastuzumab emtansine | |||
| ISH Assays | |||
| HER2 FISH pharmDx Kit | Agilent Technologies/Dako Denmark | Trastuzumab | Trastuzumab |
| Pertuzumab | |||
| Ado-trastuzumab emtansine | |||
| HER2 CISH pharmDx Kit | Agilent Technologies/Dako Denmark | Trastuzumab | |
| INFORM™ HER-2/neu | Ventana Medical Systems | Trastuzumab | |
| INFORM™ HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems | Trastuzumab | |
| Ado-trastuzumab emtansine | |||
| PathVysion® HER-2 DNA Probe Kit | Abbott Molecular | Trastuzumab | |
| SPOT-LIGHT® HER2 CISH Kit | Life Technologies Corporation | Trastuzumab | |
| VENTANA HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems | Trastuzumab | |
| NGS Assays | |||
| FoundationOne® CDx | Foundation Medicine | Trastuzumab | |
| Pertuzumab | |||
| Ado-trastuzumab emtansine | |||
IHC, Immunohistochemical; ISH, in situ hybridization; NGS, next generation sequencing.