This feasibility study demonstrated the compelling need for an innovative approach that would decrease the number of unnecessary benign biopsies while still detecting the malignancies. A high percentage of the breast biopsies that were performed in the United States have resulted in a benign diagnosis. These unnecessary biopsies create significant patient morbidity and potentially unnecessary health care costs. To detect BC, digital mammography, MRI, CT, sonography, 18F-FDG, and 99mTc-sestamibi have made significant advances.
However, these modalities have limited specificity, and all continue to produce many false-positive and false-negative results (3–12). At an average cost of $5,000–$6,000 for each biopsy, unnecessary benign biopsies represent a serious health care burden.