FoundationFocus CDxBRCA
FDA premarket approval P160018 · decided 2016-12-19
Approval details
- PMA number
- P160018
- Trade name
- FoundationFocus CDxBRCA
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2016-06-30
- Decision date
- 2016-12-19
- Days to decision
- 172 days
- Decision code
- APWD
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Cambridge, MA
- Statement
- Approval for The FoundationFocus CDxBRCA is a next generation sequencing based in vitro diagnostic device for qualitative detection of BRCA1 and BRCA2 alterations in formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue. The FoundationFocus CDxBRCA assay detects sequence alterations in BRCA1 and BRCA2 (BRCA1/2) genes. Results of the assay are used as an aid in identifying ovarian cancer patients for whom treatment with Rubraca (rucaparib) is being considered. If a patient is positive for
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