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DESCRIPTIONThe OncoVue® Breast Cancer Risk Test (InterGenetics, Inc.) is a proprietary test for which the status of multiple single nucleotide polymorphisms (SNPs) is evaluated and the results incorporated along with personal history measures to determine breast cancer risk at different times during adulthood. The test does not detect known high risk genetic factors such as BRCA mutations. OncoVue synthesizes the various risk measures into a personalized single risk estimate for premenopause, perimenopause, and postmenopause for each patient, with comparison to the average population risk at each of these life stages.
For women without a strong family history of breast cancer and at average risk prior to testing, OncoVue purports to estimate a woman’s individual risk and place her in standard-, moderate-, or high-risk groups. The results are intended to help a woman and her physician decide if more frequent exams and/or more sophisticated surveillance techniques are indicated. For women already known to be at high risk based on a family history consistent with hereditary breast cancer, the test is represented as having added value by indicating greater or lesser risk at different life stages.
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. BCRTN members will provide genetic breast cancer risk testing for their patients using OncoVue as part of a comprehensive education program to help OncoVue “at-risk” women understand their risk level and intervention strategies. BCRTN members will be selected for the network, based on a number of criteria, including quality standards of care, level of breast cancer surveillance technology, and the capability of providing patient education on genetic testing and future risk management protocols. As of July 2013, 32 participating centers (36 locations), located in 20 states, were listed on the company website. OncoVue® is not listed in the Genetic Testing Registry of the National Center for Biotechnology Information.
BREVAGen™ evaluates 7 breast cancer-associated SNPs identified in genome-wide association studies (GWAS). Risk is calculated by multiplying the product of the individual SNP risks by the Gail model risk. BREVAGen has been evaluated for use in Caucasian women of European descent age 35 years and older. Like OncoVue, BREVAGen does not detect known high-risk mutations, e.g., BRCA. According to the BREVAGen website, “suitable candidates” for testing include women with a Gail lifetime risk of 15% or greater; with high lifetime estrogen exposure (e.g., early menarche and late menopause); or with relatives diagnosed with breast cancer. BREVAGen is not suitable for women with previous diagnoses of lobular carcinoma in situ, ductal carcinoma in situ, or breast cancer, since the Gail model cannot calculate breast cancer risk accurately for such women, or for women with an extensive family history of breast and ovarian cancer. As of July 2013, approximately 40 participating centers in 17 states were listed on the company website. BREVAGen™ is listed in the Genetic Testing Registry of the National Center for Biotechnology Information.
No test combining the results of SNP analysis with clinical factors to predict breast cancer risk has been approved or cleared by the U.S. Food and Drug Administration (FDA). These are offered as laboratory-developed tests; that is, tests developed and used at a single testing site. Laboratory developed tests, as a matter of enforcement discretion, have not been traditionally regulated by FDA in the past. They do require oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the development and use of laboratory developed tests is restricted to laboratories certified as high complexity under CLIA.
Under the current regulatory program, CLIA requires that laboratories demonstrate the analytical validity of the tests they offer. However, there is no requirement for a test to demonstrate either clinical validity or clinical utility.
Genetic Testing for Hereditary Breast and/or Ovarian Cancer is addressed in a separate policy.
POLICYThe OncoVue® and BREVAGen™ breast cancer risk tests are considered investigational as a method of estimating individual patient risk for developing breast cancer.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
As of publication of this policy, the OncoVue® has not been approved by the FDA. Per Intergentics's website they will be working with the FDA to assist them in understanding the complex nature of this technology.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY10/13/2009: Policy added
11/19/2009: Approved by MPAC
11/17/2010: Policy reviewed; no changes.
10/05/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
10/22/2013: Policy description updated regarding BREVAGen™. Added BREVAGen™ to the policy statement as investigational. Deleted outdated references from the Sources section. Added CPT code 81479 to the Code Reference section.
SOURCESBlue Cross Blue Shield Association Policy # 2.04.57
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.