FoundationOne CDx, F1CDx
FDA premarket approval P170019/S039 · decided 2023-10-11
Approval details
- PMA number
- P170019
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx, F1CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-01-30
- Decision date
- 2023-10-11
- Days to decision
- 254 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of BRAF V600E in patients with non-small cell lung cancer who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.