Get started with BRACAnalysis CDx by downloading the provider overview.
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 is an FDA-approved test that quickly and accurately identifies patients with germline BRCA1/2 pathogenic variants, helping determine eligibility for targeted therapies. Designed for patients with pancreatic, breast, ovarian, or prostate cancer, this test supports timely access to PARP inhibitor treatments that may improve outcomes.
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 pathogenic variant, or 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.
For timely treatment decisions and reduced patient anxiety, knowing germline BRCA1/2 status promptly is essential. BRACAnalysis CDx provides accurate results on average 14 days of sample receipt, delivering the information you and your patients need for informed decision-making.
Quick turnaround time after sample receipt
Myriad is the industry leader in variant classification and reclassification. We use proprietary variant classification tools, including RNA testing and other cutting-edge technology, to provide comprehensive, clinically actionable and accurate results. Each variant of uncertain significance (VUS) is continually re-evaluated until a definitive classification is reached, empowering oncologists and surgeons to make confident, informed therapy decisions for their patients.
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
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 pathogenic variant in the BRCA1/2 genes.
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.
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.
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® 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 most recently approved therapeutic product labeling.
Table 1: companion diagnostic indications
The BRACAnalysis CDx® assay is for professional use only and is performed exclusively at Myriad Genetic Laboratories, Inc. site located in Salt Lake City, UT.
LYNPARZA is a registered trademark of the AstraZeneca group of companies.TALZENNA is a registered trademark of Pfizer Inc.ZEJULA is a registered trademark of the GlaxoSmithKline group of companies.
NCCN=National Comprehensive Cancer Network® (NCCN®)
Myriad Genetics, MyRisk, Precise Tumor, MyChoice, Prolaris, BRACAnalysis CDx, RiskScore, and their respective logos, are registered trademarks of Myriad Genetics, Inc. and its subsidiaries in the United States and other jurisdictions. EndoPredict and the EndoPredict logo are either trademarks or registered trademarks of Eurobio Scientific.