New Study Using Biological Dynamics’ ExoVerita Platform Validates Exosome Detection of Early-Stage Pancreatic Ductal Adenocarcinoma (PDAC)

Results show high sensitivity and specificity of ExoVita™ Pancreas, Biological Dynamics’ liquid biopsy test, which will improve current surveillance and early diagnosis of curable PDAC

SAN DIEGO – Oct. 19, 2023 – Biological Dynamics, Inc., a leader in exosome-isolation technology for early disease detection, announced a newly published study in Nature’s Communications Medicine titled “Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma.” The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort.

“Pancreatic cancer is one of the deadliest cancers and is often detected at a late stage, limiting treatment options and reducing survival rates–the 5-year survival rate is just 12.5%,” said Juan Pablo Hinestrosa, Ph.D., V.P. of Research at Biological Dynamics. “The results of this study show that by analyzing the critical information provided by exosomes and employing machine learning to develop a classifier, our technology platform can detect early-stage pancreatic cancer with high sensitivity and specificity.”

Exosomes are tiny circulating particles naturally released from cells into the bloodstream. Historically, isolating these nanoparticles has been challenging due to their low levels, small sizes, and low buoyant density. Biological Dynamics’ ExoVita Pancreas assay, powered by the ExoVerita™ platform, uses the AC Electrokinetics method for exosome isolation. The proprietary technology is proving to be a precise, automated, and cost-effective method for capturing these particles and analyzing the biomarkers they carry to provide useful information about tumors.

The study, led by Dr. Hinestrosa in collaboration with Rosalie Sears, Ph.D., Oregon Health & Science University (OHSU), used the ExoVerita platform to isolate exosomes from blood samples collected from individuals with pancreatic cancer along with healthy donors and donors at high-risk for pancreatic cancer. A training set of samples was used to develop the ExoVita Pancreas assay, which assesses cancer risk based on a multi-biomarker signature and a machine learning-based classifier scoring. The assay was subsequently validated on an independent cohort of 113 subjects (30 PDAC cases stages I and II, 83 controls), with a performance of 90.0% sensitivity and 92.8% specificity.

“Now that we are beginning to understand the important story that exosomes tell when it comes to human health and disease, novel tools and biomarker approaches are opening new frontiers for early disease detection,” said Paul R. Billings, M.D., Ph.D., CEO and Director of Biological Dynamics. “Driven by our Verita technology, the ExoVita test can detect challenging diseases like pancreatic cancer earlier than ever. With further testing in real-world settings, we are confident our exosome enabled test will be useful for high-risk surveillance and early detection of pancreatic cancer, resulting in improved patient outcomes.”

About Biological Dynamics

Biological Dynamics, Inc. is a leader in exosome-isolation technology committed to improving global health outcomes by identifying early-stage disease. Its ExoVerita™ platform offers a simple and automated workflow to enrich for exosomes, powering advanced detection tests for some of the most challenging diseases. Biological Dynamics’ ExoVita™ assays utilize the ExoVerita platform to enable reliable surveillance and early cancer detection to help enhance and extend lives. The Company operates a CAP-accredited, CLIA-certified clinical laboratory in San Diego, California. Learn more at www.BiologicalDynamics.com.