Biological Dynamics study demonstrates detection of early-stage cancers using isolated exosomes and AI

The Verita™ proprietary platform detected 96 percent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis

Biological Dynamics announces the publication of its study, Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle Protein-Based Blood Test, published in Nature Communications Medicine. The test correctly identified 71 percent of stage 1 cancers in a combined cohort of pancreatic, ovarian, and bladder cancers with pancreatic stage 1 cancer detection at 96%.

“The results are remarkable and highlight exosomal protein markers as a viable candidate for early-stage cancer detection,” said Scott Lippman, M.D., co-senior author of this report and Director of UC San Diego Moores Cancer Center. “Specifically, pancreatic cancer is notoriously difficult to detect at an early stage, when surgery, the only curative therapy, is possible. Biological Dynamics’ assay is demonstrating the potential for early-stage cancer detection to be included in the standard of care.”

The case-controlled pilot study explored a cohort of 139 pathologically staged patients with stage 1 and stage 2 pancreatic, ovarian, and bladder cancers. While other liquid biopsy approaches have shown high sensitivity in the later stages of cancer progression, they have been relatively unsuccessful in detecting cancers in earlier stages. Results from the study demonstrate that the company’s unique proprietary Verita™ platform can rapidly isolate extracellular vesicles (EVs) from 250 microliters of plasma and provide a multi-marker, protein-based analysis that clearly discriminates early-stage cancer cases from healthy controls. The method enables a unique, rapid, multiomic assessment from a single small blood draw.

Schematic showing EV isolation workflows using either Verita™
or ultracentrifugation methods

Fig. 1

a Workflow using the Verita™ Isolation platform. As plasma samples are flowed onto the energized AC Electrokinetics (ACE) microelectrode array, EVs are collected onto the electrodes. Unbound materials are removed with a buffer wash, the electric field turned off, and EVs are eluted into the buffer. b Workflow for differential ultracentrifugation. Plasma samples are diluted, and large debris pelleted by a low-speed centrifugation step. Supernatants are removed and subjected to two additional cycles of low-speed centrifugation. EVs in the cleared supernatants are then ultracentrifuged two times, and lastly the pellet is resuspended in buffer.

“Our study shows effective use of EVs isolated by the Verita™ platform for early cancer detection,” said Dr. Paul R. Billings, Biological Dynamic’s CEO and Director. “In addition to delivering the current exo-protein analysis, the platform can provide data on other exo-proteins, exosomal nucleic acids, and circulating DNA biomarkers. With our own development and in partnership, we intend to rapidly improve cancer detection and management.”

Publication of this study follows Breakthrough Device Designation granted by the U.S. Food and Drug Administration (FDA) in October 2021. It reviewed Biological Dynamic’s liquid biopsy assay, Exo-PDAC, which delivers early-stage detection of pancreatic ductal adenocarcinoma (PDAC), an aggressive and lethal form of cancer growing in incidence worldwide.


UC San Diego Press ReleaseStudy detects tell-tale proteins released into circulation by cancer cells

Hinestrosa JP, Kurzrock R, Lewis JM et al. (2022) Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test. Commun Med 2, 29. [article]

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