FoundationOne CDx (FICDx)
FDA premarket approval P170019/S038 · decided 2022-09-27
Approval details
- PMA number
- P170019
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (FICDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2022-08-29
- Decision date
- 2022-09-27
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approved removal of the companion diagnostic indication for FoundationOneĀ® CDx (FICDx) to identify patients with ovarian cancer harboring BRCA1 or BRCA2 alterations for treatment with rucaparib.
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