FoundationOne Liquid CDx
Liquid biopsy
solid tumor, pan cancer
FDA-approved blood-based comprehensive genomic profiling companion diagnostic for solid tumors.
Regulatory
| Regulatory status | PMA approved |
| FDA submission pathway | PMA |
| FDA decision date | 2020-08-26 |
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://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190032 · fda_db · 2026-04-20
How to cite this entry
Elbakri A. OncologyAI Registry: FoundationOne Liquid CDx. Available at: https://oncologyairegistry.org/tools/foundationone-liquid-cdx.html. Accessed [date].