FDA Grants Breakthrough Device Designation for Early-Stage Exosome-Based Pancreatic Cancer Detection Test from Biological Dynamics

On October 20, 2021, Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s liquid biopsy assay, Exo-PDAC. The test is designed to provide exosome-based 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.”

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