Biological Dynamics, Inc. has developed a non-invasive blood test (liquid biopsy ) that can identify early-stage disease with high sensitivity and specificity. The proprietary ExoVerita™ assay uses alternating current electric (ACE) field to isolate extracellular vesicles (EVs) for differentiated multiomics applications and includes an optimized machine learning algorithm to identify a panel of EV-bound protein biomarkers in patient's plasma in order to detect PDAC at earlier stages.~ExoLuminate is a prospective, multi-center, observational registry study designed to evaluate the non-inferiority of the performance of the ExoVerita™ assay in detecting pancreatic ductal adenocarcinoma (PDAC) in high-risk or clinically-suspicious populations in comparison to standard-of-care methods.~The study is planned to recruit a minimum of 1000 U.S. adults over 2-years (with a 1-year follow-up for data collection).~The test will be ordered through providers. Eligible subjects will be evaluated using the ExoVerita™ assay through blood donation(s) at specified time intervals. Overall, this study poses minimal risk to subject.
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in those patients that are at an elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).~Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, a family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, a personal or family history of pancreatitis, or new onset diabetes after age 50.~The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.