FoundationOne CDx, FoundationOne Liquid CDx
FDA premarket approval P170019/S022 · decided 2021-07-21
Approval details
- PMA number
- P170019
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx, FoundationOne Liquid CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2020-11-27
- Decision date
- 2021-07-21
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for the variant classification procedure to add additional variants to existing BRCA1, BRCA2 and ATM companion diagnostic claims for PARP inhibitors (e.g., rucaparib and olaparib) on FoundationOne CDx and FoundationOne Liquid CDx
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