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

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

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.