Study results will further validate the clinical importance of Biological Dynamics’ ExoVita Pancreas Assay in High-Risk individuals

Biological Dynamics, a leader in exosome-isolation technology for early disease detection, will present a poster featuring its ExoLuminate study design, currently enrolling, at The American Society of Clinical Oncology (ASCO), June 2-6, 2023 in Chicago, IL.

The detection of pancreatic ductal adenocarcinoma (PDAC) at early-stages is critical to improving patient survival. Pancreatic cancer that is diagnosed in early stages, when it is still localized, has a 5-year survival rate of over 44%, while the 5-year survival rate of cancer that has spread to distant regions is just 3.2%.¹ Historically, the lack of a clinically useful biomarker assay has posed a challenge for earlier detection. Today, Biological Dynamics’ liquid biopsy offering, ExoVita™ Pancreas, targets and isolates exosomes from patients’ blood samples to detect the likelihood of developing PDAC. Early studies show that the assay can detect pancreatic cancer at stages I and II, with high sensitivity and specificity.

“Detecting PDAC and its precursor lesions from at-risk individuals requires a test that is highly sensitive and accessible to a wide population base,” said Harmeet Dhani, MD, MSc, Medical Director, Biological Dynamics, and Principal Investigator. “The ExoLuminate study will further validate our assay, along with generating evidence of early disease in people who are at a higher risk for developing pancreatic cancer. If we can shift cancer detection to stages I or II, we believe patient survival rates may significantly improve.”

The ExoLuminate registry study (NCT05625529) is actively enrolling select academic and community centers to recruit eligible high-risk subjects for PDAC to investigate the clinical utility of ExoVita Pancreas. The assay is powered by a patented exosome-isolation technology that yields high sensitivity results from a simple blood draw. It is intended to be used with individuals and their family members who have been identified as having elevated risk for pancreatic cancer. These high-risk factors include inherited genetic mutations, family history, and the presence of lesions in the pancreas. The study duration will be 36 months (24-month accrual, 12-month follow-up), with a minimum of 1,000 subjects to be enrolled.

“The ExoLuminate study is receiving significant interest from providers, as our test is addressing a critical unmet need in early cancer detection for individuals with a higher risk of developing pancreatic cancer,” said Paul R. Billings, MD, PhD, CEO and Director of Biological Dynamics. “We’re looking forward to further validating our patented ExoVerita exosome-isolation technology and highly sensitive ExoVita Pancreas assay as important tools for earlier cancer detection and, in turn, improving patient outcomes.”

About Biological Dynamics

Biological Dynamics, Inc., is committed to improving global health outcomes by detecting early-stage diseases with its proprietary exosome-isolation technology. The ExoVerita™ platform offers a simple and automated workflow to enrich for exosomes, enabling multiomic applications. Leveraging this innovative platform, Biological Dynamics is developing early cancer detection assays for some of the most challenging cancers. Its ExoVita™ Pancreas lab-developed test (LDT), validated and performed in the Company’s College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego, detects pancreatic cancer as early as stages I and II. Currently underway, its ExoLuminate clinical study is intended to demonstrate the effectiveness of the Company's technology for early detection of pancreatic cancer in higher-risk individuals. Learn more at www.ExoLuminate.com or www.BiologicalDynamics.com.

Sources

1. SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute; 2023 Apr 19. Data source(s): SEER Incidence Data, November 2022. Submission (1975-2020), SEER 22 registries (excluding Illinois and Massachusetts). https://seer.cancer.gov/statistics-network/explorer/. Accessed May 17, 2023. 

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