Table 2.
Biomarker Name |
Type of Specimen Required |
Type of Test | Stage(s) of Disease |
Intended Use | Current Validation Status |
Commercial Availability |
---|---|---|---|---|---|---|
ColoPrint | Fresh, unfixed tumor tissue |
Gene expression profile by oligonucleotide array |
II | Prognostic marker for recurrence risk in stage II colon cancer |
Two non- randomized validation studies;64,65 PARSC trial underway66 |
Anticipated (Agendia) |
CTC | Peripheral blood collected in preservative tube |
Immunomagnetic separation of epithelial cells from whole blood |
IV | Prognostic for survival in patients with metastatic colorectal cancer |
Multiple studies including meta- analysis data and randomized subset from ==CAIRO2 study67,69 |
Multiple including CellSearch System (Veridex, LLC) |
Oncotype DX Colon Cancer Test |
FFPE tumor tissue |
Gene expression profile by RT-PCR |
II | Prognostic marker for recurrence risk in stage II colon cancer |
Independent validation in randomized subset from QUASAR study;70 second independent validation set presented at 2011 ASCO Annual Meeting71 |
Yes (Genomic Health, Inc.) |
Abbreviations: CTC, circulating tumor cells; FFPE, formalin-fixed, paraffin-embedded; PARSC, Prospective Analysis of Risk stratification by ColoPrint; RT-PCR, reverse transcriptase-polymerase chain reaction.