Early Detection of Breast Cancer in Women With Suspicious Mammograms

This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. The clinical Investigators or a member of their staff will conduct consent discussion once a suspicious mammogram report is identified or if a patient is referred for imaging of a suspicious area in the breast. After consenting the participant will be asked to donate a blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report and a medical history questionnaire. The participants will be followed after one year to capture progression or resolution of their suspicious mammogram report. After a biopsy confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be requested for research.

Inclusion Criteria: * Women who receive a suspicious mammogram report or are scheduled to receive testing for suspect breast area, with a subsequent biopsy to confirm diagnosis * Willingness and ability to donate biospecimens for the purpose of propelling research. * Participants aged ≥ 18. Exclusion Criteria: * Individuals under 18 years of age or over 89 years of age. * A known history of breast cancer. * A diagnosis or history of any other type of cancer. * Participants who are male.