The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Biological Dynamics’ Exo-PDAC, a test designed for the detection of pancreatic cancer.
The liquid biopsy assay has been developed for the early detection of pancreatic ductal adenocarcinoma (PDAC).
It is designed to identify exosomal biomarkers which are related to a high risk of pancreatic cancer.
This includes people with certain germline mutations, a family history of pancreatic cancer, new-onset diabetes, and other relevant factors that are determined by the United States Preventive Services Task Force (USPSTF).
Biological Dynamics CEO Raj Krishnan said: “For far too long, patients have needed innovative technologies with the potential to detect cancer at the earliest stages, and we look forward to working closely with the FDA, to do exactly that, with our pancreatic cancer test.
“And for us, this is an important milestone as we accelerate our vision of improving global health outcomes by advancing our unique multiomics platform for multiple cancers and other diseases.”
The diagnostic assay is claimed to be the first to use the company’s Verita platform to detect PDAC.
The new alternating current electrokinetic-based platform is used for early-stage detection of diseases such as Alzheimer’s, cancer and some infectious diseases.
Exo-PDAC uses a small amount of a patient’s blood sample, which is examined after minimal sample preparation or processing.
PDAC is one of the most lethal forms of cancer across the world and is expected to become the second main cause of deaths related to cancer by 2040.