BRACAnalysis CDx
for Patients
The Only FDA Approved Blood Test To Help Personalize Your Advanced Cancer Treatment Options
New treatment approved by the FDA for pancreatic cancer
Easy and affordable genetic testing to learn your BRCA status so you and your healthcare provider can determine what treatment is right for you
Your BRCA status could determine your eligibility for advanced cancer treatments
Only FDA approved BRCA 1 and BRCA 2 test
Affordable testing covered by majority of health plans
BRACAnalysis CDx® Overview
What is BRCA?
Everyone is born with BRCA genes. Normally, the proteins produced by the BRCA1 and BRCA2 genes prevent cells from developing into cancer. When one of these genes becomes ineffective due to an inherited mutation, the cell can no longer prevent tumors from growing, causing an increased risk for cancer.
Who should consider BRACAnaylsis CDx testing?
Medical Treatment guidelines state the following should receive germline testing1
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Advanced Cancer Treatments and BRCA
Affordability
BRACAnalysis CDx testing is broadly covered by the vast majority of health plans and with Myriad’s excellent coverage and financial assistance program most appropriate patients pay $0.
The Myriad Promise is our commitment to provide patients with accurate and affordable genetic results. 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.
Process for Testing
With a simple blood test, Myriad can let you and your physician know if you are a candidate for advanced cancer treatment.
1. Your physician takes a blood draw
2. Your sample is sent to Myriad Genetics
3. Myriad sends your results to your physician to share with you. The results indicate your eligibility for targeted therapies
- Referenced with permission from the NCCN: Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 3.2019. ©️National Comprehensive Cancer Network, Inc. 2019.
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) |
| Prostate Cancer | Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes | Lynparza® (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.
