Analysis of Serum miRNA from Women Referred for Breast Biopsy

Analysis by EarlyGuard™ of Serum miRNA from Women Referred for Additional Testing Due to Abnormal Breast Imaging Classified as BI-RADS® 3, 4 or 5

Toray Molecular Laboratory, a division of Toray International America, Inc., is conducting a 2000-patient multi-center prospective clinical trial with medical institutions in the United States to evaluate miRNA biomarkers in the blood of patients who have had an abnormal breast imaging finding and subsequently will undergo additional testing including shortened interval follow up or breast biopsy. These institutions include well-known medical centers, cancer clinics, and radiology practices in eight different states across the USA. The goal of the trial is to determine if serum miRNA signatures can be used to stratify the risk of a subsequent breast biopsy being negative or positive for breast cancer in women who have breast imaging studies with a BI-RADs 3, 4, or 5 result during routine screening. Additional validation studies will be conducted to develop a serum miRNA-based test for use in ruling out an immediate breast biopsy in those patients with a negative test result.

Principal Investigator: Lora Barke, DO