The preoperative core needle biopsy (CNB) is the standard of care for the initial evaluation of breast lesions in patients with abnormal imaging findings. Due to the sampling errors of CNB, the major concern is that these patients may harbor concurrent malignancy not captured in the small biopsy specimen. Currently, 80-95% of these patients are over-treated, as most undergo surgical excision. In addition, despite the proven benefit of chemopreventive drugs, some patients miss the opportunity to prevent or treat developing cancer at an early stage due to fear of the side
effect of these drugs. The development of a highly accurate and clinically applicable optical microscopy platform, Nano-Vision Diagnostics (NVD), aims to reduce over-treatment and to identify those patients with precancerous lesions most likely to progress to breast cancer in whom chemopreventive treatment is warranted. This project is currently in clinical trials to demonstrate the clinical utility of NVD as an adjunct diagnostic test to predict which breast patients require subsequent surgery and the feasibility of NVD to predict the risk of breast cancer progression.