Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol

Inclusion Criteria:

• Adult women from 25 years of age to below 75 years of age
• Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
• Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
• Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
• Samples collected under IRB approval and Informed Consent
• Testing performed under IRB approval or waiver (as applicable)
• Previous approved procedures to enroll patients: breast augmentation & cyst aspiration

Exclusion Criteria:

• Adults from 76 years of age or older and below 25 years of age
• Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
• Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
• Samples not collected under IRB approval and Informed Consent
• Testing not performed under IRB approval or waiver (as applicable)
• Prior breast cancer diagnosis.