BRCA Testing for
Breast Cancer

Determine which Patients with Breast Cancer are Appropriate for PARP Inhibitor Therapy

PARP inhibitor therapy is an effective treatment option for patients with HER2-negative locally advanced or metastatic
breast cancer and germline BRCA1/2 mutation.1,2 Identifying your patients with germline BRCA1/2 mutations is the first step to offering this new targeted therapy in your practice.

Learn More About BRCA Testing

Include Germline BRCA1/2 Testing in Your Metastatic Breast Cancer Workup

According to the NCCN Guidelines®, for patients with recurrent or Stage IV HER2-negative breast cancer eligible for single-agent therapy, strongly consider germline BRCA1/2 testing during patient workup.3

No family history is needed for patients with metastatic breast cancer to meet genetic testing guidelines.

Confidently Determine BRCA1/2 Status for PARP Inhibitor Therapy

BRACAnalysis CDx® was designed and FDA-approved to quickly provide accurate germline BRCA1/2 reports so you can confidently recommend an appropriate PARP inhibitor for your patient without delay. Once Myriad receives the sample, you will receive the results of the BRACAnalysis CDx test in less than two weeks.

How To Order BRACAnalysis CDx

Explore Patient Information and Indications for FDA-Approved PARP Inhibitors

Sources:
  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. Referenced with permission from the NCCN: NCCN® Genetic/Familial High-Risk Assessment: Breast and Ovarian Version 3.2019 BRCA-1. ©National Comprehensive Cancer Network, Inc. 2018.

Intended Use
PMA Intended Use Statement for 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 with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.

Table 1: Companion diagnostic indications

Tumor TypeBiomarkerTherapy
Breast CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Talzenna® (talazoparib)
Ovarian CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)-
treatment/maintenance
Rubraca® (rucaparib)
Pancreatic CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)
Prostate CancerDeleterious or suspected deleterious mutations in BRCA1 and BRCA2 genesLynparza® (olaparib)

Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations by the BRACAnalysis CDx test in ovarian cancer patients is also associated with enhanced progression-free survival (PFS) from Zejula® (niraparib) or Rubraca® (rucaparib) maintenance therapy.

This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108

Limitation: In Ovarian Cancer, ~70% of tumor BRCA1 or BRCA2 mutation positive patients are estimated to have a germline mutation while ~30% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from a patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in ovarian cancer patients does not rule out the possibility of a somatic BRCA1 or BRCA2 mutation in tumor tissue from these patients.

Limitation: In Prostate Cancer, ~50% of tumor BRCA1 or BRCA2 mutation positive patients are estimated to have a germline mutation while ~50% of patients are estimated to have a somatic mutation. The BRACAnalysis CDx test detects germline mutations only, not somatic mutations from patient’s blood sample. A negative result using the BRACAnalysis CDx blood test in prostate cancer patients does not rule out the possibility of a somatic BRCA1 or BRCA2 mutation in tumor tissue from these patients.