Jenna Gillen

In 1153 women undergoing breast imaging and NCB, BIRADS 5 status, symptomatic presentation, and age over 70 years were associated with shorter time to biopsy, while socioeconomic and demographic factors were not significant predictors of delay.

In this prospective multicenter study, the next-generation MarginProbe device (MP2) achieved sensitivity of 76.8% and specificity of 49.1% for intraoperative lumpectomy margin assessment, meeting all predefined success criteria and earning FDA approval in September 2025.