Biological Dynamics, Inc., a company commercializing its exosome-isolation ExoVerita™ platform for early disease surveillance and other applications, today announced completion of the analytical and clinical validation of its lab developed test (LDT), ExoVita™ Pancreas in the company’s CLIA certified and CAP accredited laboratory.
Using blood-based exosome samples enriched on the proprietary ExoVerita instrument, the ExoVita Pancreas assay measures specific exosomal protein biomarkers and has been demonstrated to detect Stage 1 and Stage 2 pancreatic ductal adenoma carcinoma (PDAC)1.
With this validation, samples from the ExoLuminate registry trial (NCT05625529), a trial which has already begun actively enrolling patients with high-risk for PDAC to investigate the test’s clinical utility, will be tested by the company. Eligible patients include those with a familial or genetic predisposition, an individual’s clinical symptoms such as pancreatitis or known pancreatic lesions, and newly diagnosed diabetics over the age of 50.
“Our published, high sensitivity ExoVita Pancreas assay for early-stage pancreatic cancer is being further validated with prospective clinical samples from our ExoLuminate registry trial. Further leveraging the unique power of our ExoVerita platform, we plan to address additional cancer indications soon,” said Harmeet Dhani, MD, MSc, Director of Medical Affairs at Biological Dynamics. “Our expertise in isolating information rich exosomes, coupled with the unique clinical validity demonstrations, will significantly improve patient care.”