FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P190032/S008 · decided 2022-12-19
Approval details
- PMA number
- P190032
- Supplement
- S008
- Supplement type
- Real-Time Process
- 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
- 2022-09-26
- Decision date
- 2022-12-19
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for FoundationOneĀ® Liquid CDx (FILCDx) label expansion to obtain companion diagnostic group labeling claim for patients with non-small cell lung cancer harboring EGFR exon 19 deletions or EGFR exon 21 L858R mutations for treatment with any one of the FDA-approved EGFR Tyrosine Kinase Inhibitors (TKI).
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