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

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.