FoundationOne Liquid CDx (F1 Liquid CDx)
FDA premarket approval P190032/S001 · decided 2021-07-15
Approval details
- PMA number
- P190032
- Supplement
- S001
- 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
- 2020-08-28
- Decision date
- 2021-07-15
- Days to decision
- 321 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 detection of MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping in non-small cell lung cancer patients who may benefit from treatment with TABRECTA (capmatinib)
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