Biological Dynamics collaborates on clinical utility studies to examine the impact of its early pancreatic cancer detection assay

2022-11-22

临床研究

The company partners with QURE and Curta to assess value of early identification in high-risk cohorts

SAN DIEGO, Nov. 22, 2022 /PRNewswire/ -- Biological Dynamics, an exosome-isolation technology and early disease detection diagnostic company, today announced that it has partnered with both QURE Healthcare and Curta to explore how the company's assay for early detection of pancreatic ductal adenocarcinoma (PDAC) can improve patient outcomes, demonstrate the greatest value to clinicians, and enhance healthcare economics.

Earlier PDAC detection has the potential to improve the survival and quality of life for high-risk patients. However, there is a need to understand physician adoption to enhance clinical decisions affecting treatment, patient outcomes, and the use of finite healthcare resources. Therefore, Biological Dynamics will help conduct independent studies on how providers will use its early PDAC detection assay and how the test performance and cost may impact downstream patient care and curative interventions that payors review for reimbursement coverage decisions.

"We believe our technology ventures well beyond the DNA-based sequencing tests available for PDAC to the serial imaging that has been the standard for detecting pancreatic cancer for decades," said Paul R. Billings, M.D., Ph.D., F.A.C.P., F.A.C.M.G.G., CEO and Director of Biological Dynamics. "We must more fully understand the risks and benefits of early detection methods in all individuals including those at high-risk for pancreatic cancer. These two studies will add important observations as we evolve to better management of disease risk and sensitive diagnoses."

Curta develops models that characterize how new health technologies can influence care and outcomes in the real world. The Curta study for Biological Dynamics will explore the potential health and economic outcomes of early PDAC detection with the Biological Dynamics' PDAC assay from a US payor perspective. It is hypothesized that shifting diagnoses from regional and distant stages to the localized stage in high-risk adults will result in improved survival and quality of life.

"A blood test is much easier to administer for patients compared to a battery of imaging technologies. It can make clinical flow easier by saving unnecessary tests when the PDAC assay is negative," said Scott D. Ramsey, M.D, Ph.D., Senior Partner and CMO at Curta. Dr. Ramsey went on to say "Our modeling will characterize the current standard of care for surveillance of patients with high risk for pancreatic cancer. Our model will provide scenarios where the assay can improve guideline adherence, potentially reducing costs and improving outcomes — and put this evidence into a framework that payors will understand. Ultimately, we are hopeful it will improve the state of evidence supporting future guidelines."

QURE Healthcare measures clinical practice patterns among physicians to understand how new technologies will affect patient care. The QURE study for Biological Dynamics will investigate if use of the company's PDAC assay would alter physician behavior using a randomized controlled trial with QURE's Clinical Performance and Value (CPV®) patient simulations.

"The study will provide evidence-based outcomes to determine if the assay will change clinical decisions when managing patients at high risk for PDAC as well as those presenting with symptoms of possible pancreatic cancer," said John Peabody, M.D., Ph.D., FACP President of QURE Healthcare and Professor at the University of California, San Francisco. "This is an enormously complicated area with a paucity of evidence around guidelines and preventive care. We are enrolling physicians now in a randomized controlled trial so that we can uniquely determine if this leads to an earlier evaluation. We are excited about the assay and its potential to dramatically change medicine," Dr. Peabody continued.

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 PDAC assay, for early detection of the aggressive and lethal pancreatic ductal adenocarcinoma in high-risk populations. Its AACC award-winning PDAC assay operates in a College of American Pathologists (CAP) accredited, CLIA-certified clinical laboratory in San Diego. For more information visit www.biologicaldynamics.com or LinkedIn.

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SOURCE Biological Dynamics