Women with a Breast Imaging Reporting and Data System (BI-RADS) mammogram score of 3 or 4 often pose a diagnostic and management conundrum for radiologists. These women fall into a gray diagnostic zone where the subjective nature of image analysis can prevent a definitive diagnosis, and patients often wait for reimaging in six months, during which time some may have progression of invasive breast cancer and some with benign lesions face a nervous waiting game. Provista Diagnostics (New York City) is developing a comprehensive proteomic panel that can better differentiate benign lesions from invasive breast cancer, in conjunction with standard imaging. “In lay terms, BI-RADS 3 is ‘most likely benign’ and BI-RADS 4 is ‘possibly malignant,’ and most BI-RADS 3s are sent away to re-examine in six months. But, 1 percent to 2 percent sent away will actually have invasive breast cancer,” David Reese, Ph.D., Provista’s CEO tells DTET. “This is problematic for radiologists, with 40 percent of medical malpractice suits for breast cancer radiologists resulting from the BI-RADS 3-4 juncture. We hope to give radiologists a way to go home and know that their nos are actually nos.” The company recently presented results of a randomized trial of 351 […]