Table 2.
In vitro companion diagnostic kits currently licensed by the Food and Drug Administration (FDA).
| Biomarker | Prevalance | Indication | Drug | Assay Kit | Technology | Manufacturer |
|---|---|---|---|---|---|---|
| HER2 gene amplification | 22.2% [47] | Breast cancer | trastuzumab (Herceptin) | Inform | FISH | Ventana Medical Systems |
| PathVysion # | FISH | Abbott Molecular Inc. | ||||
| SPOT-Light HER2 | CISH | Life Technologies | ||||
| InSite HER2 | IHC | Biogenex Laboratories, Inc. | ||||
| HercepTest | IHC | Dako Denmark | ||||
| HER2 PharmDx | CISH | Dako Denmark | ||||
| HER2 PharmDx * | FISH | Dako Denmark | ||||
| PATHWAY Her2 | IHC | Ventana Medical Systems | ||||
| Bond Oracle | IHC | Leica Biosystems | ||||
| EGFR protein expression | 60%–80% [48] | Colorectal cancer | cetuximab (Erbitux) panitumumab (Vectibix) | EGFR pharmDx | IHC | Dako North America |
| c-Kit protein expression | 100% [49] | Gastrointestinal stromal tumours | imatinib (Gleevac) | c-kit pharmDx | IHC | Dako North America |
| ALK gene rearrangement | 7.5% [50] | Non-small cell lung cancer | crizotinib (Xalkori) | VYSIS | FISH | Abbott Molecular Inc. |
| BRAF p.V600E mutation | 75.4% [51] | Melanoma | vemurafenib (Zelboraf) | Cobas 4800 | Real-time PCR | Roche Molecular Systems, Inc |
| KRAS mutation | 30%–60% [52] | Colorectal cancer | cetuximb (Erbitux) | therascreen | Real-time PCR | Qiagen |
* Indicated for assessment of breast cancer patients considered for pertuzumab (Perjeta) or # cyclophosphamide, doxorubicin, 5-FU treatment.