Clear Information for Physicians, Genetic Counselors, Healthcare Providers, and Health Plan Professionals

A comprehensive volume of evidence-based evaluations of BRCA1/2 testing in patients affected with, or at high risk for, hereditary breast and/or ovarian cancer is available from the Hayes enetic Test Evaluation (GTE) Program.

Women who carry a change in one of the breast cancer susceptibility genes, BRCA1 or BRCA2, have an increased risk of breast and ovarian cancer; however, only 5% of cases of breast or ovarian cancer are caused by these hereditary genetic changes. With the growing number of women and men requesting genetic testing to determine their risk, healthcare professionals need clear information to help them understand the complexities of BRCA1/2 gene testing, including how to:

1. Identify women and men for whom BRCA1/2 testing will provide a benefit.
2. Determine when it is appropriate to perform rearrangement testing versus sequence analysis.
3. Understand the implications of ambiguous results, as well as positive and negative results.

While there is demonstrated clinical utility of performing this testing in the right patient population, there is also evidence that these tests are often inappropriately used in some patient populations, creating challenges for health plans and other stakeholders.^1,2 At >$3,500 per test (including both sequencing and rearrangement testing), insurance policies vary in regard to which patients are eligible for coverage and how much of the cost is covered.

Written in a format and language that can be understood by both the clinician and non-clinician, these reports provide clear information and recommendations regarding each of these tests in different patient populations:

1. Women and men with breast cancer
2. Women and men at risk for breast cancer due to a positive family history
3. Women affected with ovarian cancer
4. Women at risk for ovarian cancer due to a positive family history

Each analysis includes information on clinical validity, analytical validity, clinical utility, cost, major payer coverage policies, genetic counseling recommendations, and what the future holds for genetic testing for hereditary breast and ovarian cancer.

Terms & Conditions: Hayes reports are proprietary, protected by copyright, and available only by purchase. By agreeing to purchase, the purchaser understands that the Hayes report(s) are for internal use only and that they may only be utilized in the facility of the purchaser and may not be transmitted to, or circulated in any other office or facility. Use of the Hayes report(s) for advertising, product support or endorsement of the technology by Hayes, either orally or in writing, in materials prepared and/or distributed by the manufacturer or its employees, agents, consultants, subsidiaries, distributors or other third party affiliates is prohibited.

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_{1. Pinkowish MD. Family physicians and referrals of low-risk women for BRCA1/2 genetic services. CA Cancer J Clin. 2009;59(2):70-72.}

_{2. White DB, Bonham VL, Jenkins J, Stevens N, McBride CM. Too many referrals of low-risk women for BRCA1/2 genetic services by family physicians. Cancer Epidemiol Biomarkers Prev. 2008;17(11):2980-2986.}