BRCA mutations are responsible for the majority of hereditary breast and ovarian cancer.4,5,6 Patients with a mutation in either the BRCA1 or BRCA2 gene have risks of up to 87% for breast cancer and up to 44% for ovarian cancer by age 70.4,6,7,8,9 Mutation carriers previously diagnosed with cancer also have a significantly increased risk of developing a second primary (new) cancer.8,10,11Genetic testing identifies patients who have germline mutations in the BRCA1 and BRCA2 genes. This information is useful when developing risk-reducing strategies for these patients.
How is BRACAnalysis Performed?
There are now two ways to obtain a sample from the patient for analysis: A small amount of blood can be drawn or an oral sample can be taken using a buccal rinse. The sample is sent to Myriad for DNA sequencing analysis of BRCA1 and BRCA2.
How long does it take for BRACAnalysis results?
Results usually take two weeks and are sent to either the ordering healthcare provider or a designated “mail to” provider identified on the test request form.
Will a patient’s health insurance cover the test?
Most health insurance plans pay for BRACAnalysis. Patients typically pay co-insurance of less than 10% of the test price. Myriad will notify you before processing your test if you total financial responsibility exceeds $375 (or $15 per month when utilizing our interest-free 25-month payment plan) for any reason, including co-insurance, deductible, or non-covered services. Call Myriad at 800-469-7423 for more details.
Can a health insurance provider discriminate against a patient based on BRACAnalysis results?
Federal and state governments recognize the value of genetic information to patients and doctors and have put specific legal protections in place. The Genetic Information Nondiscrimination Act or GINA adds additional protection to existing legal protections that are in place at both the federal and state levels. GINA is a federal law that protects Americans from being treated unfairly based on differences in their DNA. GINA prevents discrimination from health insurers and employers. Health insurers are prohibited from requesting or requiring an individual or family member to undergo a genetic test or requesting, requiring, or purchasing genetic information, nor can they use an individual’s genetic information in setting eligibility, premium or contribution amounts by group and individual health insurers. GINA also protects individuals from employers requesting, requiring, or purchasing genetic information about an individual employee or family member. In addition, the employer is prohibited from using an individual’s genetic information in employment decisions such as hiring, firing, job assignments and promotions.
The Health Insurance Portability & Accountability Act (HIPAA) recognizes genetic information as Protected Health Information (PHI) and specifies protecting its confidentiality. HIPAA further states that “genetic information shall not be treated as a pre-existing condition in the absence of a diagnosis of the condition related to such information,” e.g., a diagnosis of hereditary cancer. The Americans with Disabilities Act (ADA) provides additional protections regarding the use of genetic information by employers.
Almost all states have additional laws that protect people from various forms of health insurance and employment discrimination based on genetic information. For more information about how these laws apply to you, go to the National Human Genome Research Institute.
If a patient has already had breast cancer, what does a positive BRACAnalysis result indicate?
Individuals with a BRCA1 or BRCA2 mutation are at a greater risk for developing a new ovarian or breast cancer. Knowing a patient’s BRCA status can help you to develop a management plan to reduce this risk, or detect another potential cancer at an earlier, more treatable stage. Importantly, a patient’s test results may also have significant meaning for the health of his or her family members.
If no one in her family has had ovarian cancer, should a woman with a BRCA1 or BRCA2 mutation still be concerned?
A woman who carries a BRCA1 or BRCA2 mutation is at increased risk for both breast and ovarian cancer-even if there are no known cases of ovarian cancer in the family.
Is BRACAnalysis appropriate for men?
Any male with a personal history of breast cancer or a significant family history of breast or ovarian cancer may have a BRCA1 or BRCA2 mutation. If a family member has a BRCA1 or BRCA2 mutation, he may have inherited that mutation. Men in this situation should consider testing. Although male breast cancer is rare, men who carry BRCA mutations are more likely to develop breast or prostate cancer. These men also have a 50% chance of passing the mutation on to their children, whether or not they have been diagnosed with cancer.