Table 2.
Commercially available molecular tests
| Mammaprint™ | Oncotype DXTM | EndoPredict™ | ProsignaTM | |
|---|---|---|---|---|
| Provider | Agendia | Genomic Health | Sividon | NanoString |
| Type of assay | 70-gene assay | 21-gene RS | 11-gene assay | 50-gene assay |
| Type of tissue | fresh frozen | FFPE | FFPE | FFPE |
| Technique | DNA microarrays | qRT-PCR | qRT-PCR | qRT-PCR |
| Central laboratory | yes | yes | no | no |
| Indication and population studied | prognostic, N0–1 | prognostic, N0–1 ER+ | prognostic, N0–1 ER+/HER2− | prognostic, N0–1 |
| Analytical validation | yes | yes | yes | yes |
| Clinical validation | yes | yes | yes | yes |
| Prospective-retrospective evidence | observational feasibility | NSABP B-14 (14%), | ABCSG 6 (19%), | MA.12 (49%), |
| (% of recruited patients) | study (RASTER) (73%) | NSABP B-20 (28%), | ABCSG 8 (36%), | MA.5 (66%), |
| SWOG 8814 (40%), | GEICAM/9906 (64%) | ABCSG 8 (40%), | ||
| ATAC (30%) | ATAC (16%), | |||
| GEICAM/9906 (66%) | ||||
| Prospective evidence (pending) | MINDACT | TAILORX, RxPONDER, ADAPT | ||
| CTS | C | B | B | B |
| LoE2009 | II | I | I | I |
| AGO recommendation | +/− | +a | +a | +/− |
AGO = Arbeitsgemeinschaft für Gynäkologische Onkologie, CTS = category of tumor marker studies, ER = estrogen receptor, FFPE = formalin-fixed paraffin-embedded, HER2 = human epidermal growth factor receptor 2, LoE = level of evidence, qRT-PCR = quantitative reverse transcription-polymerase chain reaction, RS = recurrence score.
a
Should only be used in selected node-negative patients if all other criteria are inconclusive for therapeutic decision-making.