Table 1.
IHC biomarker assays for FFPE tissues.
| Biomarker | Cancer type | Year of approval or clearance | Clinical use |
|---|---|---|---|
| FDA approved single IHC biomarkers | |||
| p63 protein | Prostate | 2005 | Nuclear basal cell marker for differential diagnosis |
| c‐Kit (CD117) | Gastrointestinal stromal tumours | 2004 | Diagnosis |
| Estrogen receptor (ER) | Breast | 1999 | Prognosis, response to therapy |
| Progesterone receptor (PR) | Breast | 1999 | Prognosis, response to therapy |
| HER‐2/neu | Breast | 1998 | Prognosis, response to therapy |
| Biomarker assay | Cancer type | Company | Clinical use |
|---|---|---|---|
| Emerging panel‐based IHC biomarker assays | |||
| Mammostrat® (p53, HTF9C, CEACAM5, NDRG1 and SLC7A5 IHC combined with a defined mathematical algorithm) | Breast | Clarient InsightDx® | Recurrence risk index for hormone‐receptor positive, early stage breast cancer, independent of proliferation and grade |
| IHC4 (AQUA® Technology combined with ER/PR, HER2 and Ki‐67 IHC). | Breast | Genoptix® Medical Laboratory | Recurrence risk assessment |