Abstract OT2-10-01: The VIOLA study: Validating individualized breast cancer screening by offering a new link in access
Authors: Anna Daily
Journal: Cancer Research (2022)

Abstract The VIOLA Study is a Clinical Utility Study designed to investigate the useability of Melody®, a tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. It is well established that disparities exist in breast health, preventative care, and screening mammography. Namida Lab believes in the potential of Melody® to be a tool that bridges the gap between underserved populations and positive health outcomes. As such, Namida Lab, Inc. is partnering with federally qualified health centers and large employers to evaluate the clinical utility of Melody®. Melody® consists of two parts: tear sample collection and clinical lab assay. Participants will have a tear sample collected at a study site. The clinical lab assay, Melody®, will be performed at Namida Lab, Inc. The results of the Melody® assay will be returned to the site clinician to be discussed with the participant. The administration of Melody® does not require additional appointments or trips and can be done by any member of a medical team. A minimum participation of 205 women who are 40 to 74 years of age, at average risk for developing breast cancer, asymptomatic, and have no concerns or breast abnormalities. To date 28 participants have been enrolled in the study. Study enrollment and eConsent will be conducted through our mobile application. Each participant will be required to take an enrollment survey that collects information on race, ethnicity, and socio-economic status. Participant's addresses will be obtained as part of the requisition process for the CLIA lab, from which information on geographic location can be obtained. In addition to the factors listed above, the enrollment survey also collects information on status and type of health insurance, reproductive health, breast health knowledge, prior screening history, and family and personal history of cancer The exit survey has been designed to collect information on the participant experience with Melody® and comprehension of the Melody® results relayed through their site clinician. In addition, information is collected on participant''s intention to schedule/participate in future screening mammograms and/or change in intention to participate in a previously scheduled screening mammogram. Primary endpoint: The VIOLA Study is designed to assess how incorporating Melody® into a primary care provider setting affects participation and confidence in the current breast health continuum of care. Secondary endpoint: Quantifying the relationship between Melody® and increased participation in breast health care offers the clinical utility evidence required for adoption into the Standard of Care. Citation Format: Anna Daily. The VIOLA study: Validating individualized breast cancer screening by offering a new link in access [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-10-01.