Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening

Primary Objective: Determine clinical performance metrics of the Syantra blood test in a population of women 30-75 years of age. Secondary Objectives: Investigate the role of ethnicity, geography, and participant characteristics (including breast density and elevated risk of breast cancer development) on test performance. Investigate tumor characteristics and test development. Study Design: Non-randomized, blinded, non-interventional, longitudinal, multi-center Investigational Device: Syantra blood test Population: Women age 30-75 years testing for the presence of breast cancer as part of regular breast screening or planned follow-up diagnostic imaging and/or biopsy Accrual Goal: 2,000 women Primary Endpoint: Clinical performance of the Syantra blood test in the primary population Procedure: Participants providing consent and meeting eligibility criteria will complete a baseline questionnaire (demographics and medical history) and have their blood drawn prior to surgical procedure or biopsy (if applicable). Participant medical records will be reviewed to collect relevant history, including imaging studies, surgery, and pathology results, along with medical treatments and patient status. Follow-up: Medical records for participants will be reviewed and updated after completion of diagnostic procedures (within 60 days) and at 12 months post baseline blood draw to complete recording of procedures and status, including interval cancers or other newly diagnosed diseases. Participants with incomplete records or follow-up will be reviewed annually for imaging, pertinent medical issues, and/or outcomes for up to 5 years. Biospecimen Retention: De-identified blood samples stored for up to 20 years.