FDA Designates Biological Dynamics’ Pancreatic Cancer Test a Breakthrough Device

The FDA has designated Biological Dynamics’ liquid biopsy assay, Exo-PDAC (pancreatic ductal adenocarcinoma), as a breakthrough device.

The assay is designed to detect PDAC, an aggressive and lethal form of cancer early in the course of the disease in high-risk adults.

The assay does this by identifying biomarkers associated with an elevated risk of pancreatic cancer, such as seen in individuals with new-onset diabetes, a family history of pancreatic cancer or certain germline mutations, the company said.