The clinical utility studies planned with the two partners will evaluate the impact of the PDAC assay in enhancing patient outcomes, improving healthcare economics, and delivering benefits for clinicians
Biological Dynamics is partnering with QURE Healthcare and Curta to assess its assay in the early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk cohorts.
The US-based exosome-isolation technology and early disease detection diagnostic firm said that the clinical utility studies with the two partners will evaluate the impact of its PDAC assay in enhancing patient outcomes, improving healthcare economics, and demonstrating benefits for clinicians.
Biological Dynamics announced independent studies to better understand how providers will use its early PDAC detection assay.
The test performance and cost related to subsequent patient care and curative interventions that payors evaluate for reimbursement decisions will also be analysed, the firm added.
Biological Dynamics CEO and director Paul Billings said: “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.
“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 is engaged in developing models to demonstrate how new medical technologies may affect actual care and results.
Biological Dynamics said that the Curta study will examine the potential economic and health effects of early PDAC identification using its PDAC assay.
Curta senior partner and CMO Scott Ramsey said: “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.
“Our modelling will characterise the current standard of care for surveillance of patients with high risk for pancreatic cancer.”
According to Biological Dynamics, QURE Healthcare measures physicians’ clinical practice patterns to understand how new technology may impact patient care.
The Clinical Performance and Value (CPV) patient simulations used in the QURE study will be used in a randomised controlled trial to see whether adopting the PDAC assay would change physician behaviour, the company added.