eClinical Technology and Industy News

FDA Grants Breakthrough Device Designation for Biological Dynamics’ Early-stage Pancreatic Cancer Detection Test

Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its liquid biopsy assay, Exo-PDAC. The test is designed to provide early detection for pancreatic ductal adenocarcinoma (PDAC), one of the most aggressive and lethal forms of cancer worldwide.

Early detection of pancreatic cancer in elevated risk individuals may help save a lot of lives,” said Scott Lippman, MD, Director of Moores Cancer Center at UC San Diego Health. “The promise of Biological Dynamics’ cutting-edge exosomal isolation technology is addressing a critical, unmet medical need in our multidisciplinary and multi-dimensional fight against pancreatic cancer.”

PDAC is projected to become the second leading cause of cancer-related deaths by 2040, due primarily to the fact that the disease is asymptomatic in its early stages. Therefore, patients are typically diagnosed during advanced stages of disease progression when treatments are limited. Detecting early PDAC biomarkers could help identify vulnerable patients before the disease progresses or metastasizes. However, it requires a high degree of sensitivity and specificity that conventional laboratory testing methods lack.

The Exo-PDAC diagnostic assay identifies exosomal biomarkers related to an elevated risk of pancreatic cancer, such as individuals with new-onset diabetes, a family history of pancreatic cancer, certain germline mutations, and other relevant factors that might be determined by the United States Preventive Services Task Force (USPSTF). Exo-PDAC is the first assay to use Biological Dynamics’ Verita™ platform, a novel alternating current electrokinetic-based technology applied for early disease detection, including cancer, Alzheimer’s disease, and infectious diseases. The test requires a small amount of blood from patients, which is then analyzed with minimal sample preparation or processing.

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