FoundationOne Liquid CDx
FDA premarket approval P190032/S015 · decided 2024-11-14
Approval details
- PMA number
- P190032
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-11-01
- Decision date
- 2024-11-14
- Days to decision
- 379 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/S015) to include a companion diagnostic indication to identify patients with non-small cell lung cancer harboring MET single nucleotide variants (SNVs) and insertions and deletions (indels) that lead to MET exon 14 skipping alterations who are eligible for treatment with Tepmetko® (tepotinib).
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