FoundationFocus™ CDxBRCA

The FDA-approved companion diagnostic test for Rubraca™ (rucaparib)
A PARP inhibitor therapy for BRCA-mutated ovarian cancer

Uncover More BRCA Mutations with a Single Tissue Test

FoundationFocus CDxBRCA detects deleterious BRCA1/2 mutations that may be:

Germline (inherited)

Somatic (acquired)

to identify women for whom treatment with Rubraca™ (rucaparib) may be considered.

More Patients on Therapy Sooner

By testing tumor tissue for BRCA1/2 mutations, FoundationFocus CDxBRCA can help identify up to twice as many women1-3,5 who may benefit from PARP inhibitor therapy. Conventional tests only look for germline alterations in blood or saliva. FoundationFocus CDxBRCA analyzes ovarian cancer tumor tissue to detect BRCA1/2 mutation types associated with response to PARP inhibition.1,4

Learn More

Download Test Requisition Form

Download Specimen Guidelines

Download Sample Report

Indications, Contraindications, and Limitations

1 Hennessy BTJ, et al. Somatic mutations in BRCA1 and BRCA2 could expand the number of patients that benefit from poly (ADP ribose) polymerase inhibitors in ovarian cancer. JCO. 2010;28(22):3570-6.

 

2 Pennington KP, et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas. Clin Cancer Res. 2013;20(3):764-75.

 

3 Arts-de Jong M, et al. Germline BRCA1/2 mutation testing is indicated in every patient with epithelial ovarian cancer: A systematic review. Eur J Cancer. 2016;(61):137-145.

 

4 Moschetta M, George A, Kaye SB, Banerjee S. BRCA somatic mutations and epigenetic BRCA modifications in serous ovarian cancer. Ann Oncol. 2016 Aug;27(8):1449-55.

 

5 The ratio of germline to somatic BRCA alterations varies based on population studied.

 

RubracaTM (rucaparib) is a product of Clovis Oncology.