Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)

Cohort 1: Screening Population - Women presenting for routine XRM and / or breast US.

Cohort 2: Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.

Inclusion Criteria:

Screening Population:

• Subject signed the informed consent.
• Subject is aged 25 years and older.
• Subject is presenting for routine screening or diagnostic XRM and / or breast US.

Breast Cancer Population

• Subject signed the informed consent form.
• Subject is aged 25 years and older.
• Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.

Exclusion Criteria:

All Subjects:

• Subject has been diagnosed with any type of malignancy apart from breast cancer.
• Subject has been previously treated for breast cancer.
• Subject underwent any surgery within the previous year (apart from benign nevus removal).
• Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
• Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
• Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
• Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
• Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
• Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
• Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
• Subject is pregnant, lactating, or undergoing fertility treatment.
• Subject has participated in this study, in another cohort, and the TM-B1 test was performed.

Breast Cancer Population only:

• The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.