{"entity":{"id":"foundationfocus-cdxbrca","kind":"drug","name":"FoundationFocus CDxBRCA","aka":["FoundationFocus CDxBRCA Assay"],"tldr":"Foundation Medicine's first FDA-approved test, a BRCA test for rucaparib in ovarian cancer, since withdrawn in the FDA database.","summary":"FoundationFocus CDxBRCA was approved on 19 December 2016 (PMA P160018) as the companion diagnostic for rucaparib in ovarian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 FoundationOne CDx, Foundation Medicine's broader panel, carries BRCA claims of its own.","status":"withdrawn","asOf":"2026-11-03","links":[{"label":"FDA PMA P160018","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160018"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["foundationone-cdx","brca-somatic"],"cancers":["ovarian"],"sections":[],"technologies":["companion-diagnostic"],"targets":["brca"],"drugs":["rucaparib"],"companies":["foundation-medicine"],"institutions":[],"pathways":[],"terms":["ngs","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["PMA P160018 shows a withdrawal date of 14 March 2025 in the FDA PMA database (read 3 November 2026)."],"brand":"FoundationFocus CDxBRCA","modality":"Tissue NGS companion diagnostic test (BRCA1 and BRCA2)","mechanism":"Next-generation sequencing of ovarian tumour tissue for BRCA1 and BRCA2 alterations.","approvals":[{"region":"US","year":2016,"indication":"Companion diagnostic for rucaparib in ovarian cancer (BRCA1 and BRCA2 alterations)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/foundationfocus-cdxbrca/","neighbours":{"drug":[{"id":"foundationone-cdx","kind":"drug","name":"FoundationOne CDx / Liquid CDx","route":"/drugs/foundationone-cdx/"},{"id":"rucaparib","kind":"drug","name":"Rucaparib","route":"/drugs/rucaparib/"}],"biomarker":[{"id":"brca-somatic","kind":"biomarker","name":"Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations","route":"/biomarkers/brca-somatic/"}],"cancer":[{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"}],"company":[{"id":"foundation-medicine","kind":"company","name":"Foundation Medicine (Roche)","route":"/companies/foundation-medicine/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}]}}