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

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