# BRACAnalysis CDx

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

## TL;DR

The inherited BRCA test that decides who can have PARP inhibitor pills for ovarian, breast, pancreatic and prostate cancer.

## Summary

Approved 19 December 2014 (PMA P140020) as the companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer, the first FDA-approved companion diagnostic based on an inherited variant. Claims followed for olaparib and talazoparib in HER2-negative metastatic breast cancer (2018), olaparib maintenance in first-line ovarian cancer (SOLO-1, 2018), pancreatic cancer (POLO, 2019), metastatic castration-resistant prostate cancer (PROfound, 2020) and early breast cancer (OlympiA, 2022). Myriad's monopoly on BRCA testing ended with the 2013 US Supreme Court ruling that isolated genes cannot be patented, and multi-gene hereditary panels have since become the norm, but BRACAnalysis CDx remains the labelled test.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: BRACAnalysis CDx
- Modality: Germline BRCA1/2 sequencing companion diagnostic test
- Mechanism: Sanger and NGS sequencing plus large-rearrangement analysis of germline BRCA1 and BRCA2 from blood, classifying variants as deleterious or suspected deleterious.
- Approvals: US 2014: Companion diagnostic for olaparib in germline BRCA-mutated advanced ovarian cancer; US 2018: Olaparib and talazoparib in germline BRCA-mutated HER2-negative metastatic breast cancer; US 2019: Olaparib maintenance in germline BRCA-mutated metastatic pancreatic cancer; US 2020: Olaparib in germline BRCA-mutated metastatic castration-resistant prostate cancer

## Notes

- What a result means: a pathogenic BRCA1/2 variant makes PARP inhibitors an option, raises the case for risk-reducing surgery or surveillance, and means blood relatives can be tested.
- Pancreatic ductal adenocarcinoma: POLO selected patients on a germline BRCA1/2 result from this assay, the companion diagnostic for olaparib maintenance (Golan 2019).

## Sources

- FDA PMA P140020: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140020

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Germline (hereditary) testing](https://onco.cc/technologies/germline-testing/), [HRD & BRCA testing](https://onco.cc/technologies/hrd-testing/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [PARP](https://onco.cc/targets/parp/)
- drugs: [Olaparib](https://onco.cc/drugs/olaparib/), [Talazoparib](https://onco.cc/drugs/talazoparib/)
- companies: [Myriad Genetics](https://onco.cc/companies/myriad-genetics/)
- terms: [Germline BRCA mutation (gBRCA)](https://onco.cc/terms/gbrca-mutation/), [Germline vs somatic mutations](https://onco.cc/terms/germline-vs-somatic/)
- trials: [SOLO-1](https://onco.cc/trials/solo-1/)
- key papers: [Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer](https://onco.cc/key-papers/paper-couch-tnbc-germline-17-genes-jco-2015/), [POLO: maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer](https://onco.cc/key-papers/paper-polo-olaparib-maintenance-gbrca-pancreatic-nejm-2019/)
- biomarkers: [Germline BRCA1/2 pathogenic variant (gBRCAm)](https://onco.cc/biomarkers/brca-germline/)

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