For clarity, Auria's indication for usage is the following: Auria® is a biological breast cancer screening test intended to be used in conjunction with standard-of-care testing. Auria® is not a replacement for a screening mammogram. It is important to understand that Auria is NOT a diagnostic test for breast cancer but is a screening tool to assess risk and to activate women to take the first step to better breast health, addressing the 54% of American women not getting their annual mammograms and hopefully to assist the early identification of diseases for the 1 in 8 women who will get breast cancer in their lifetime.
Auria® is intended as a short-term breast health assessment for women ages 30 and over. Assigned classifications are associated with the indication that protein levels detected by the Auria® test may be associated with the development of an abnormality in the breast tissue. Auria® is not a diagnostic test for breast cancer.
Auria® uses composite algorithmic analysis of tear protein biomarkers. Quantitative values of individual biomarkers are not reportable and are not associated with individual biomarker result reference ranges.