![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Foundation Medicine Garners FDA Approval for Companion Device for Rubraca
Foundation Medicine Garners FDA Approval for Companion Device for Rubraca
![](https://www.fdanews.com/ext/resources/test/Device_Images4/FDA_Logo_Large.gif?t=1486528488&width=430)
The FDA has granted approval to Foundation Medicine’s FoundationFocus CDxBRCA to aid in identifying women with ovarian cancer who are treated with Rubraca.
The device is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations in ovarian cancer.
FoundationFocus CDxBRCA is an assay developed from the quality systems regulations - compliant version of Foundation Medicine’s CGP assay. — Cynthia Jessup
Upcoming Events
-
11Jul
-
18Jul
-
21Oct