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.