Biological Dynamics announces prospective clinical trial, ExoLuminate™
/SAN DIEGO, Dec. 1, 2022 /PRNewswire/ -- Biological Dynamics, a company developing its exosome-isolation ExoVerita™ platform for early disease diagnostics, announced today it has received IRB approval and will soon begin to enroll patients in its ExoLuminate™ clinical study to validate its pancreatic ductal adenocarcinoma (PDAC) lab-developed test (LDT).
"Using novel data, we are one of the first companies in this country to use exosome-isolation for early detection of pancreatic disease. We are accelerating its application by initiating the ExoLuminate registry trial, which will enroll for high-risk or clinically suspicious patients and their family members that share risk factors," said Harmeet Dhani, MD, MSc, Director of Medical Affairs at Biological Dynamics.
The average five-year survival rate for patients diagnosed with pancreatic cancer is 11.5%, which is driven largely by current methods that detect PDAC at late stages. The five-year survival rate improves to 44% when patients are diagnosed at the localized, earlier stages when surgical resection can be curative. But this only constitutes about 12% of diagnosed pancreatic cancer patients. There may be benefit to earlier, stage-shifting of patients (Clinical data source: SEER NCI database).
"Our PDAC assay can detect pancreatic cancer as early as Stages 1 and 2, and the data from this study will provide prospective evidence for the benefit of earlier detection of disease. Early detection could be a pivotal step that can lessen disease burden and alleviate emotional and economic impacts to patients, their families, and our healthcare system," continued Dr. Dhani.
Razelle Kurzrock, MD, FACP, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin Cancer Center, said "Although most pancreatic cancer is diagnosed at a late stage and is almost uniformly lethal, when pancreatic cancer is detected at Stage 1 (as can be achieved using exosome-isolation on the ExoVerita platform), survival rates can be as high as 80%. This promising research suggests the assay could become an integral diagnostic component for pancreatic cancer management."
Biological Dynamics' PDAC assay targets extracellular vesicles (EVs), specifically exosomal PDAC associated protein biomarkers in blood. The test is being further evaluated in the ExoLuminate clinical study [NCT 05625529]. "We believe our PDAC assay can improve diagnostic data quality and surgical decision making. We intend to revolutionize cancer care through early detection," said Paul R. Billings, MD, PhD, FACP, FACMGG, CEO and Director of Biological Dynamics. Dr. Billings served on the Scientific Advisory Board of the Food and Drug Administration, the Genomic Medicine Advisory Committee at the Department of Veterans Affairs, and the HHS Secretary's Advisory Committee on Genomics, Health and Society. His work formed the basis of the Genetic Information Nondiscrimination Act of 2008 (GINA)
For more information about the ExoLuminate clinical study, please visit www.clinicaltrials.gov.
About Biological Dynamics
Biological Dynamics, Inc. is committed to improving global health outcomes by detecting diseases at the earliest stages. The company's proprietary ExoVerita™ platform simplifies isolation of extracellular vesicles, enabling multiomic applications. In 2021, the U.S. Food and Drug Administration granted Breakthrough Device Designation for its liquid biopsy assay for early detection of the aggressive and lethal pancreatic ductal adenocarcinoma in high-risk populations. Its AACC award-winning PDAC test operates in a College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. Healthcare providers can register patients and learn about eligibility criteria for the ExoLuminate study by emailing ExoLuminate@biologicaldynamics.com. Visit www.ExoLuminate.com or LinkedIn.
