FoundationOne Liquid CDx
FDA premarket approval P190032/S021 · decided 2024-05-17
Approval details
- PMA number
- P190032
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-04-18
- Decision date
- 2024-05-17
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for the removal of the companion diagnostic (CDx) indication for FoundationOne Liquid CDx to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertions for treatment with EXKIVITY (mobocertinib).
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