Know your BRCA status for cancer treatment decisions.
More treatment options are available when you know your BRCA status.
A one-size-fits-all approach in the treatment of cancer can create a risk of patients being over or under-treated. If you have been diagnosed with breast, ovarian, pancreatic or prostate cancer, knowing your BRCA status could determine your eligibility for advanced cancer treatments.
BRACAnalysis CDx is a simple blood test to let you and your physician know if you are a candidate for these treatments, and is the only germline BRCA1/2 test approved by the FDA.
Everyone is born with BRCA genes, and the proteins produced by the BRCA1 and BRCA2 genes normally prevent cells from developing into cancer. When one of these genes becomes ineffective due to an inherited mutation, the cell has a hard time preventing tumors from growing, causing an increased risk for cancer.
Cancer cells with a germline BRCA1/2 mutation are more vulnerable to treatments that directly or indirectly damage their DNA. If you carry a BRCA mutation, your cancer cells are less likely to be repaired and may die with the help of advanced cancer treatments like PARP inhibitory therapy.
BRACAnalysis CDx testing is broadly covered by the vast majority of health plans, and most appropriate patients pay $0.
At Myriad, we believe every patient should have access to the highest quality testing so their healthcare providers can deliver the best medical care possible. When one of our tests is ordered for you, we will work with your insurance provider to help you get the appropriate coverage allowed by your plan.
If you have questions about billing or coverage, please call Myriad at 800-469-7423 for more details.
To understand your BRCA status and eligibility for advanced cancer treatments, download the BRACAnalysis CDx patient guide and ask your doctor about getting BRCA testing to guide your treatment options.
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.
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 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.
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