FoundationFocus CDx BRCA HRD
FDA premarket approval P160018/S001 · decided 2018-04-06
Approval details
- PMA number
- P160018
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationFocus CDx BRCA HRD
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2017-09-28
- Decision date
- 2018-04-06
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Cambridge, MA
- Statement
- Approval for the FoundationFocus™ CDx BRCA LOH. The device is an assay that uses next-generation sequencing (NGS) for qualitative detection of BRCA1 and BRCA2 sequence alterations and genomic loss of heterozygosity (LOH) from formalin-fixed, paraffin-embedded (FFPE) ovarian tumor tissue. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious tumor BRCA variants (tBRCA-positive), who may be eligible for treatment with Rubraca (rucaparib). Positive homologou
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