MammaPrint
Genomic + AI
breast
FDA-cleared 70-gene expression signature for recurrence risk stratification in early-stage breast cancer.
Regulatory
| Regulatory status | De Novo authorized |
| FDA submission pathway | De Novo |
| FDA decision date | 2007-02-06 |
| FDA 510(k) number | K070675 |
Validation summary
Validation summary not yet populated. This entry currently lists only the regulatory pathway and headline citation; structured cohort and endpoint data are queued for v0.3.
| Study design | — |
| Cohort size | — |
| Number of validation sites | — |
| Site geography | — |
| Comparator | — |
| Primary endpoint | — |
| Primary result | — |
| External validation | — |
| Peer-reviewed | — |
| FDA decision summary | — |
Deployment
| Available | Yes |
Sources
- https://agendia.com/mammaprint/ · company · 2026-04-20
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm · fda_db · 2026-04-20
How to cite this entry
Elbakri A. OncologyAI Registry: MammaPrint. Available at: https://oncologyairegistry.org/tools/agendia-mammaprint.html. Accessed [date].