FoundationOne Liquid CDx (F1LCDx)
FDA premarket approval P190032/S004 · decided 2022-12-22
Approval details
- PMA number
- P190032
- Supplement
- S004
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne Liquid CDx (F1LCDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2022-04-13
- Decision date
- 2022-12-22
- Days to decision
- 253 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval to include a companion diagnostic indication for NTRK1, NTRK2, and NTRK3 fusions in patients with solid tumors and for ROS1 fusions in patients with non-small cell lung cancer who may benefit from treatment with ROZLYTREK® (entrectinib).
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