OncoVue® is performed on patients 30 to 69 years of age, and is intended as an aid in the qualitative assessment of breast cancer risk. OncoVue® is not intended as a stand-alone test for the determination of breast cancer risk in women. OncoVue® results are intended for use by physicians as a predictive tool only in conjunction with other breast cancer risk assessment tools such as the Gail Model, family history, lifestyle factors, breast density and other clinical factors which may contribute to breast cancer risk. OncoVue® results require post-test consultation by qualified medical personnel familiar with breast cancer risk assessment. OncoVue® is not intended for sale outside of the InterGenetics-qualified ordering facilities and the CLIA-certified InterGenetics laboratory. OncoVue® is not intended for diagnosis, prediction or detection of response to therapy, or to help select the optimal therapy for patients.