BRACAnalysis CDx®
Germline Companion Diagnostic Test

Identify patients with germline BRCA1/2 mutations who may be eligible for certain targeted therapies

Order a test kit

BRACAnalysis CDx®
Germline Companion Diagnostic Test

Identify patients with germline BRCA1/2 mutations who may be eligible for certain targeted therapies

Order a test kit

Provider guide

Intended use

Confidently recommend an appropriate PARP inhibitor for patients with breast, ovarian, pancreatic and prostate cancer

BRACAnalysis CDx is an FDA-approved test used to identify patients with germline BRCA1/2 mutations who may be eligible for certain targeted therapies without delay. This test quickly and accurately provides results for patients with pancreatic cancer, breast cancer, ovarian cancer, and prostate cancer who may benefit from PARP inhibitor treatment.

NCCN Guidelines® recommend germline BRCA1/2 testing for patients with breast, ovarian, pancreatic, and prostate cancer1

  • All patients with a personal diagnosis of breast, ovarian, pancreatic and prostate meet criteria for genetic testing. No family history is required for eligibility
  • Testing at diagnosis can help you determine an appropriate treatment plan for your patients

Turnaround time matters

You and your patients need to know their germline BRCA1/2 status quickly to minimize anxiety while they wait for a result. BRACAnalysis CDx can report your patients’ germline BRCA1/2 status in less than two weeks after we receive the sample.

There is also a priority option for patients with pancreatic cancer with a one-week turnaround time. This accelerated process requires the use of the priority label for patients with pancreatic cancer.

FDA-approved targeted therapies

Tumor type Biomarker Therapy
Breast Cancer Ribbon Breast cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)
Ovarian Cancer Ribbon Ovarian cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
    • treatment / maintenance
  • Rubraca® (rucaparib)
Pancreatic Cancer Ribbon Pancreatic cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)
Prostate Cancer Ribbon Prostate cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)

The importance of variant classification

43-63% of gBRCA mutations identified as VUSs at competing labs can be definitively classified using Myriad’s variant classification program.2

Myriad Genetic Laboratories has over 25 years of experience in variant classification and reclassification of BRCA1/2. The resulting analysis and interpretation of the variants reduces the VUS rate in genetic test results and provides confidence for oncologists when determining the appropriate therapy for their patients.

VUS = variant of uncertain significance

Intended use – PMA intended use statement for BRACAnalysis CDx

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 type Biomarker Therapy
Breast cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)
Ovarian cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
    • treatment / maintenance
  • Rubraca® (rucaparib)
Pancreatic cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)
Prostate cancer Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
  • LYNPARZA® (olaparib)
  • Talzenna® (talazoparib)

Detection of deleterious or suspected deleterious germline BRCA1 and BRCA2 mutations by 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 and 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 and BRCA2 mutation in tumor tissue from these patients.

Limitation: in prostate cancer, ~50% of tumor BRCA1 and 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 and BRCA2 mutation in tumor tissue from these patients.

LYNPARZA is a registered trademark of the AstraZeneca group of companies.

References:
  1. Referenced with permission from the NCCN: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. Version 2.2021. ©National Comprehensive Cancer Network, Inc. 2020
  2. Gradishar W, et al. Clinical variant classification: a comparison of public databases and a commercial testing laboratory. Oncologist. 2017;22(7):797-803

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