Table 5.
CDxs targeting HER2 mutation for breast cancer
| FDA-approved companion diagnostic | FDA-approved therapeutic products | ||
|---|---|---|---|
| Herceptin® (trastuzumab) | Kadcyla® (ado-trastuzumab emtansine) | Perjeta® (pertuzumab) | |
| INFORM HER-2/neu | x | – | – |
| PathVysion HER-2 DNA Probe Kit | x | – | – |
| PATHWAY anti-Her2/neu (4B5) Rabbit Monoclonal Primary Antibody | x | x | – |
| InSite Her-2/neu KIT | x | – | – |
| SPOT-LIGHT HER2 CISH Kit | x | – | – |
| Bond Oracle HER2 IHC System | x | – | – |
| HER2 CISH pharmDX Kit | x | – | – |
| Inform HER2 Dual ISH DNA Probe Cocktail | x | x | – |
| HerceptTest | x | x | x |
| HER2 FISH pharmDx Kit | x | x | x |
| Ventana HER2 Dual ISH DNA Prob | x | – | – |