FoundationOne CDx
FDA premarket approval P170019/S015 · decided 2020-05-19
Approval details
- PMA number
- P170019
- Supplement
- S015
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2019-12-16
- Decision date
- 2020-05-19
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval to expand the intended use of FoundationOne®CDx to include a companion diagnostic indication for homologous recombination repair (HHR) gene alterations in patients with metastatic castration resistant prostate cancer who may benefit from treatment with Lynparza®(olaparib).
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