This study is a retrospective and prospective study aimed to develop and validate the performance of multi-omics assays for early detection of female breast cancer. The study will enroll approximately 496 participants including participants with breast cancers and participants with breast benign diseases.

Inclusion Criteria for All Participants:

• Able to provide a written informed consent.
• Female, at least 18 years old.

Additional Inclusion Criteria for Breast Cancer Participants:

• Pathologically confirmed breast cancer diagnosis or highly suspicious for breast cancer within 42 days prior to blood draw.
• No prior cancer treatment before the blood draw.

Additional Inclusion Criteria for Breast Benign Disease Participants:

• Pathologically confirmed breast cancer diagnosis or highly suspicious of breast benign diseases within 90 days prior to blood draw.
• No prior radical treatment before the blood draw.

Exclusion Criteria for All Participants:

• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 7 days prior to blood draw.
• Recipient of anti-tumor drugs to treat non-cancer diseases prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen).

Additional Exclusion Criteria for Breast Cancer Participants:

• Multiple primary tumors.

Eligible participants will be recruited from medical centers and assigned into two arms, including participants with new diagnosis of breast cancer or breast benign disease.