BRACAnalyaisCDxProviderThumb

Take the next step with BRACAnalysis CDx®

Get started with BRACAnalysis CDx by downloading the provider guide.

Take the next step with BRACAnalysis CDx®

Whether you’ve heard about genetic testing before or want to learn more, we can help provide in-depth information on the test and your testing options.

BRACAnalysis CDx®
Germline Companion Diagnostic Test

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

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.

BRACAnalysis CDx®
Germline Companion Diagnostic Test

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

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.

Germline BRCA1/2 testing helps you make the most effective treatment decisions for your patients

Germline BRCA1/2 status is a critical biomarker to help you determine the appropriate therapy for your patients with breast, ovarian, pancreatic, or prostate cancer. Cancer cells with a germline BRCA1 and/or BRCA2  mutation are more vulnerable to targeted therapies like PARP inhibitors.

BRACAnalysis CDx was designed and FDA-approved to quickly provide accurate germline BRCA1/2 reports so you can confidently recommend an appropriate PARP inhibitor without delay.

BRCA1/2 cancer types graphic

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

  • No family history is required for patients with these cancers to meet genetic testing guidelines.
  • Testing at diagnosis can help you quickly determine an appropriate treatment plan for your patients.

Breast cancer guidelines have changed

Updated breast cancer professional guidelines recommend germline testing for every breast cancer patient. The OlympiA clinical trial provides additional evidence that germline BRCA1/2 testing is imperative for your patients’ treatment selection.

BRACAnalysis CDx® is the only germline test approved by the FDA as a companion diagnostic for treatment with PARP inhibitors, as defined by the OlympiA trial.

Download the OlympiA clinical summary

Confidently recommend an appropriate PARP inhibitor with fast, accurate germline BRCA1/2 results

The results of each test component, along with the interpretation of variant(s) identified, will be delivered within 2 weeks (or 1 week for expedited pancreatic cancer testing). If multiple variants are detected, the overall test interpretation most relevant to patient management is based on the most severe variant identified.

FDA-approved targeted therapies for BRACAnalysis CDx

Tumor type Biomarker Therapy
Breast cancer

Pancreatic cancer

Prostate 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

Turnaround time matters for treatment decisions

You and your patients need to know their germline BRCA1/2 status quickly to make timely treatment decisions and minimize anxiety. BRACAnalysis CDx can report your patients’ germline BRCA1/2 status in less than two weeks after we receive the sample.

BRACAnalysis CDx also has 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.

Quick turnaround time after sample receipt

1 week priority label for patients with pancreatic cancer

Choose a test that brings you clarity in variant classification

Myriad Genetic Laboratories has over 30 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.

43-63% of germline BRCA mutations identified at competing labs as variants of uncertain significance (VUS) can be definitively classified using Myriad’s variant classification program.2

How to test with BRACAnalysis CDx

A blood test is submitted to Myriad as part of the BRACAnalysis CDx test kit. Providers also have the option of reflex testing to a larger gene panel if the patient does not have a mutation in the BRCA1/2 genes.

A blood test is submitted to Myriad with BRACAnalysis CDx

One simple order. Comprehensive results.

With Precise™ Oncology Solutions, you can receive results for comprehensive germline testing, tumor profiling and companion diagnostic options, including BRACAnalysis CDx, in one single ordering experience, getting clear, fast answers for your patients.

What to expect with every BRACAnalysis CDx test

Accurate

Myriad believes in providing the most accurate and highest quality tests for patients. From hereditary cancer to precision medicine, our tests are designed to give providers and patients the most accurate answer possible.

Actionable

Every BRACAnalysis CDx test provides actionable results within 14 days to inform cancer treatment decisions. Our results are easy to read and provide the necessary information to make important medical treatment decisions.

Affordable

Myriad is committed to providing patients with access to accurate and affordable genetic results through extensive coverage with most insurance plans and financial assistance programs. 98% of patients eligible for BRACAnalysis CDx pay $0 out of pocket.

BRACAnalysis CDx resources

BRACAnalysisCDx Logo

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)
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 in accordance with the most recently approved therapeutic product labeling.

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.
BRACAnalyaisCDxProviderThumb