# FoundationFocus CDxBRCA

Source: https://onco.cc/drugs/foundationfocus-cdxbrca/  
OnCo record `foundationfocus-cdxbrca` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Foundation Medicine's first FDA-approved test, a BRCA test for rucaparib in ovarian cancer, since withdrawn in the FDA database.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.

## Fields

- Kind: Test
- Status: withdrawn
- Last checked: 2026-11-03
- Also known as: FoundationFocus CDxBRCA Assay
- Tags: test
- 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: US 2016: Companion diagnostic for rucaparib in ovarian cancer (BRCA1 and BRCA2 alterations)

## Notes

- PMA P160018 shows a withdrawal date of 14 March 2025 in the FDA PMA database (read 3 November 2026).

## Sources

- FDA PMA P160018: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160018
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [FoundationOne CDx / Liquid CDx](https://onco.cc/drugs/foundationone-cdx/), [Rucaparib](https://onco.cc/drugs/rucaparib/)
- biomarkers: [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)
- cancers: [Ovarian cancer](https://onco.cc/cancers/ovarian/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/)
- companies: [Foundation Medicine (Roche)](https://onco.cc/companies/foundation-medicine/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)

---
JSON: https://onco.cc/api/v1/entities/foundationfocus-cdxbrca.json