ExoLuminate is a nationally-enrolling registry study designed for earlier detection of
cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal
adenocarcinoma (PDAC).
Those with elevated risk for PDAC can include individuals with intraductal papillary
mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes
known to be associated with cancer, and a personal or family history of pancreatitis.
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05625529.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Name Not Available
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationBiological Dynamics
Principal InvestigatorHarmeet Dhani
