FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P190032/S023 · decided 2024-10-10
Approval details
- PMA number
- P190032
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne Liquid CDx (F1 Liquid CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-05-31
- Decision date
- 2024-10-10
- Days to decision
- 132 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 Liquid CDx (F1LCDx) (P190032/S023) to include a companion diagnostic indication to identify patients with breast cancer with PIK3CA-mutations for treatment with ITOVEBI (inavolisib) in combination with palbociclib and fulvestrant.
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