• Germline BRCA1 and BRCA2 status is a critical biomarker to help determine the appropriate therapy for patients with metastatic breast, ovarian, metastatic pancreatic, and metastatic prostate cancers

  • BRACAnalysis CDx was designed to quickly provide accurate results for treatment recommendations

  • Identifying patients with a BRCA1/2 mutation makes it possible to utilize targeted therapy to more precisely identify and attack cancer cells. Testing for BRCA1/2 allows therapy to be personalized based on the biology of a patient1-3


Fact Sheets and Product Info:

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Executive Summary

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About BRACAnalysis CDx:

BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.

Results of the test are used as an aid in identifying patients who are or may become eligible for treatment for targeted therapies. See intended use statement for complete details.


1. Robson et al. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med (2018). 377:523-533.

2. Litton et al. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA mutation. N Engl J Med 2018;379:753-63.

3. Moore et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med (2018). DOI: 10.1056/NEJMoa1810858.