Hereditary Breast, Ovarian, Pancreatic, and Prostate Cancer Syndrome BRCA1/2 Panel
Use
This test is intended for individuals with relevant features who have a clinical or suspected diagnosis of hereditary breast, ovarian, pancreatic, and prostate cancer syndrome. It is also suitable for those with early-onset breast cancer diagnosed before age 45 years or ovarian cancer, or a personal history of multiple primary cancers. Individuals with a family history suggestive of hereditary breast, ovarian, pancreatic, and prostate cancer syndrome or of Ashkenazi Jewish ancestry with personal or family history of such cancers are also candidates.
Special Instructions
Not all tests are FDA approved or cleared; they are performed in compliance with CAP and CLIA regulations at the PreventionGenetics laboratory. Prior authorization and payment responsibility details are required, and testing may be placed on hold for financial or benefit investigation reasons. The use of the test must be ordered by a qualified healthcare provider.
Limitations
This test has not been cleared or approved by the US Food and Drug Administration. The performance characteristics are validated by PreventionGenetics, a wholly owned subsidiary of Exact Sciences Corporation, following CAP and CLIA regulations. Specificity and sensitivity details are not provided. Genetic counseling is recommended to address the implications of test results.
New York Approved
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14-21 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
Not provided
Minimum Volume
Not provided