DESCRIPTION
Non-BRCA breast cancer risk assessment (e.g. OncoVue® Breast Cancer Risk Test, InterGenetics, Inc., Oklahoma City, OK) integrates genetic testing for 22 single nucleotide polymorphism variants with personal health risk factors, such as age at first menses and first live birth and the number of first-degree relatives having breast cancer, to formulate a personalized single-risk estimate for breast cancer. The test does not detect known high-risk genetic factors (BRCA mutations) associated with hereditary breast and ovarian cancer. This proprietary test is not intended as a stand-alone test for the determination of breast cancer risk but rather as an aid in determining the qualitative assessment of risk. The test results are intended to assist the physician in planning future breast surveillance frequency and sophistication.
The OncoVue® test is available only through the Breast Cancer Risk Testing Network (BCRTN), described as a network of Breast Care Centers engaged in frontline genetic identification of breast cancer risk levels in their patients.
POLICY
Non-BRCA breast cancer risk assessment as a method of estimating an individual’s risk for developing breast cancer is considered investigational.
See also:
Genetic Testing for BRCA1, BRCA2 or CHEK2 for Breast or Ovarian Cancer
Serum Tumor Markers for Breast Malignancies
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Given the lack of published detail regarding the non-BRCA breast cancer risk assessment (OncoVue®) test validation, supportive data, and management implications, there is insufficient evidence to determine if the test provides clinical utility, i.e., whether using non-BRCA breast cancer risk estimates in asymptomatic individuals changes management decisions and improves patient outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2010) Non-BRCA breast cancer risk assessment (2.04.57). Retrieved November 12, 2010 from Blue Web. (8 articles and/or guidelines reviewed)
Gail, M. (2009) Value of added single nucleotide polymorphism genotypes to a breast cancer risk model. Journal of the National Cancer Institute, 101 (13), 959 - 963. (Level 4 evidence - Independent)
Mealiffe,M., Stokowski, R., Rhees, B., Prentice, R., Pettinger, M., & Hinds, D. (2010) Assessment of clinical validity of a breast cancer risk model combining genetic and clinical information. Journal of the National Cancer Institute, 102 (21), 1618 – 1627. (Level 4 evidence - Independent)
Wacholder, S., Hartge, P., Prentice, R., Garcia-Closas, M., Feigelson, H., Diver, W., et al. (2010). Performance of common genetic variants in breast cancer risk models. New England Journal of Medicine, 362 (11), 986-993. (Level 4 evidence - Independent)
ORIGINAL EFFECTIVE DATE: 4/14/2011
MOST RECENT REVIEW DATE: 4/14/2011
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.