Table 1 Prognostic multigene signatures in breast cancer commercially available or in commercial development
Signature | Oncotype DX [52] | MapQuant DX/simplified [55] | Veridex 76-gene [54] | ||
|---|---|---|---|---|---|
Commercially available/Provider | Yes/Agendia BV (Amsterdam, The Netherlands) | Yes/Genomic Health (Redwood City, CA, USA) | Yes/bioTheranostics, Inc.(San Diego, CA, USA) | Yes/Ipsogen Inc. (Stamford, CT, USA) | No/Johnson & Johnson (New Brunswick, NJ, USA) |
Study population | ER+ and ER-, N0, <5 cm diameter, age <55 years | ER+, N0, TAM treated | ER+, N0 | ER+ and ER-, N0 and N+ | ER+ and ER- |
Assay | 70-gene signature | 21-gene Recurrence Score | 2-gene HOXB13:IL17R/molecular-grade index | 97-gene signature/8-gene PCR | 76-gene signature |
Platform | Microarray (Agilent Technologies, Inc., Santa Clara, CA, USA) | RT-PCR | RT-PCR | Microarray (Affymetrix, Santa Clara, CA, USA)/RT-PCR | Microarray (Affymetrix) |
Tissue type | Frozen or stabilized mRNA | FFPE | FFPE | Frozen/FFPE | Frozen |
Prognostic value in other populations | Age 55-70 years, 1-3 N+, N0 and N+, HER2+ | ER+ and 1-3 N+, ER+ postmenopausal receiving aromatase inhibitors | - | ER+ receiving aromatase inhibitors | Â |
Predictive value | Neoadjuvant and adjuvant CT (poor signature) | Neoadjuvant and adjuvant CT [71] (high-RS), response to TAM (low-RS) | Resistance to TAM (high-ratio) | Response to neoadjuvant CT (high-risk) | Response to TAM (high-risk patients) |
Indication | Prognostic in N0, <5 cm diameter, stage I/II BC, | Prediction of recurrence risk in ER+ and N0 BC treated with TAM | Prognostic in ER+ BC, prediction of response to TAM | Molecular grading, for ER+, histological grade II BC | Prognostic in ER+ BC |
Level of evidence | III | II | III | III | III |
FDA approval | Yes | No | No | No | No |
Randomized trial | MINDACT | TAILORx | - | - | - |
Availability | Europe and USA | Europe and USA | USA | Europe | - |