ExoLuminate Study for Early Detection of Pancreatic Cancer

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 3-years (with a 2-year follow-up for data collection).

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.

Inclusion criteria

• ≥18 years old.
• Meeting criteria for one of the study cohorts.
• Capable of giving informed consent.
• Able to provide a blood sample.

Exclusion criteria

• < 18 years old.
• Pregnancy.
• Active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies).
• Prior organ transplant or bone marrow transplant.
• History of fainting or other adverse effects when blood is drawn.
• Any condition that, in the opinion of the investigator, should preclude enrollment.