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Foundation Medicine's first FDA-approved test, a BRCA test for rucaparib in ovarian cancer, since withdrawn in the FDA database.
FoundationFocus CDxBRCA was approved on 19 December 2016 (PMA P160018) as the companion diagnostic for rucaparib in ovarian cancer with BRCA1 or BRCA2 alterations. The FDA PMA database records a withdrawal date of 14 March 2025, although the test still appeared on the FDA companion diagnostic list when both were read on 3 November 2026. FoundationOne CDx, Foundation Medicine's broader panel, carries BRCA claims of its own.
Next-generation sequencing of ovarian tumour tissue for BRCA1 and BRCA2 alterations. Connects to BRCA1 / BRCA2 (HRD).
| Region | Year | Indication |
|---|---|---|
| US | 2016 | Companion diagnostic for rucaparib in ovarian cancer (BRCA1 and BRCA2 alterations) |
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Query for this drug: (TITLE:"FoundationFocus CDxBRCA" OR ABSTRACT:"FoundationFocus CDxBRCA" OR TITLE:"FoundationFocus CDxBRCA Assay" OR ABSTRACT:"FoundationFocus CDxBRCA Assay") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about FoundationFocus CDxBRCA, not a curated reading list.
Shares Companion diagnostic, Companion diagnostics, Ovarian cancer and the tag test.
Shares Companion diagnostic, Next-generation sequencing (NGS), Companion diagnostics and the tag test.
Shares Companion diagnostic, Next-generation sequencing (NGS), Companion diagnostics and the tag test.
Shares Foundation Medicine (Roche), FoundationOne CDx / Liquid CDx, Next-generation sequencing (NGS) and the tag test.
Shares Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Companion diagnostics, BRCA1 / BRCA2 (HRD), Ovarian cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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