This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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 homologous recombination deficiency (hrd) status (defined as tbrca-positive or loh high) in ovarian cancer patients is associated with improved progression-free survival (pfs) from rubraca (rucaparib) maintenance therapy. See the rubraca product label for information about guiding therapy in specific clinical circumstances. This test is to be performed at foundation medicine, inc. , a single laboratory site, located at 150 second street, cambridge, massachusetts.
| Device | FoundationFocus CDx BRCA HRD |
| Classification Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| 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 |
| Notice Date | 2018-04-23 |
| PMA | P160018 |
| Supplement | S001 |
| Product Code | PQP |
| Docket Number | 18M-1446 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FOUNDATION MEDICINE, INC 150 Second Street, 1st Floor cambridge, MA 02141 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160018 | Original Filing | |
| S001 | 2017-09-28 | Panel Track |