The primary objective of this study is to determine if Melody® is an effective option in breast cancer screening. This will be assessed by comparing the score and classification produced from the Melody assay to the current gold standard, screening Mammograms.~The primary endpoint will be assessed by calculating the sensitivity, specificity, PPV, and NPV for Melody compared to results of imaging.~The secondary objective of this study is to obtain provider insight and recommendation as to the potential clinical utility of Melody® as a breast cancer screening option.~The secondary endpoint will be achieved through a provider roundtable discussion. After completion of enrollment and evaluation of tear samples and time will be arranged, either in person or virtual, to review the Melody® scores determined for the sites patient population. Providers will be allowed to verbally review the process and give their thoughts on the utility of Melody within their clinic and how they feel it should be used. A member of the Namida Lab clinical team will be present to take note. After the discussion a report will be generated and the site providers will be allowed to review it for accuracy. Sites will be given a copy of their participants Melody scores as well as the summary of the provider roundtable discussion. Sites may request to have the participants results blinded if prior to review if preferred.
This study will explore and better understand the value, usage, and benefits of Melody®, a tear-based screening test for breast cancer as a supplemental tool for screening mammogram. Melody® was developed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.