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

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
• •* 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.
• •* 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.
• •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