FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P190032/S010 · decided 2023-06-08
Approval details
- PMA number
- P190032
- Supplement
- S010
- Supplement type
- Panel 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
- 2022-11-22
- Decision date
- 2023-06-08
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for the FoundationOne Liquid CDx (F1 Liquid CDx). The device expands the indications for use to include a companion diagnostic indication for the detection of BRAF V600E alteration in patients with metastatic colorectal cancer (CRC) who may benefit from treatment with BRAFTOVI® (encorafenib) in combination with cetuximab.
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