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

1. Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer. A. Asymptomatic Screening Inclusion Criteria * Age ≥ 30 and ≤ 75 * Planned MRI (for women who qualify) and/or planned screening mammogram (and/or breast ultrasound) * Presentation of factor(s) indicating elevated risk for breast cancer development o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or 1.67% or greater 5-year breast cancer risk using the BCSC model * Willing and able to give Written Informed Consent and provide a whole blood sample Exclusion Criteria * Physical breast symptoms or concerns * Current or suspected cancer diagnosis * Prior BI-RADS 3 or higher imaging results in last 12 months * Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months * Previous history of any cancer, except for non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) * Previous history of invasive or non-invasive breast cancer * Concomitant or other concurrent anti-cancer therapy * Blood transfusions within the past 3 months * Born biologically male B. Recall Inclusion Criteria * Age ≥ 30 and ≤ 75 * Previous MRI (for women who qualify) and/or screening mammogram (and/or breast ultrasound) indicating follow-up imaging or biopsy recommended * Presentation of factor(s) indicating elevated risk for breast cancer development o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or BOADICEA v6.0 or 1.67% or greater 5-year breast cancer risk using the BCSC model. * Willing and able to give Written Informed Consent and provide a whole blood sample Exclusion Criteria * Physical breast symptoms or concerns * Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months * Current diagnosis or history of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) * Blood transfusions within the past 3 months * Born biologically male 2. Recall (Secondary care) Symptomatic population: Women recommended for follow-up due to physical symptoms. This includes recommendation for diagnostic imaging and/or biopsy due to physical symptoms. Inclusion Criteria * Age ≥ 30 and ≤ 75 * Planned diagnostic breast imaging (mammogram, breast MRI and/or breast ultrasound) and/or breast biopsy, as recall or follow-up from prior examination or to evaluate breast symptom. * Willing and able to give Written Informed Consent and provide a whole blood sample. Exclusion Criteria * Current known cancer diagnosis * Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months * History of any cancer, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) * Blood transfusions within the past 3 months * Born biologically male 3. Asymptomatic average, low or unknown risk population: Women undergoing routine screening for breast cancer. Women in the Screening population would have no physical symptoms and be consented near the time of a screening imaging session (within 3 months). Recruitment may also occur after a screening imaging session with a recommendation for follow-up imaging, or after diagnostic imaging with a recommendation for a biopsy as part of the recall population. Inclusion Criteria * Age ≥ 30 and ≤ 75 * Screening mammogram and/or breast ultrasound, breast MRI within 3 months * Willing and able to give Written Informed Consent and provide a whole blood sample Exclusion Criteria * Physical breast symptoms or concerns * Breast surgery within the previous 12 months (for any reason) or breast biopsy (including needle core biopsy) within the last 12 months * History of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) * Blood transfusions within the past 3 months * Born biologically male