Paragonix Technologies, an organ transplant company, has launched a new molecular diagnostics study to expand data collection in post-transplant monitoring.
The launch of a new sub-study within the cardiac research domain is expected to expand the GUARDIAN Registry. This initiative aims to deepen the understanding and management of post-transplant rejection, with a special emphasis on molecular diagnostics.
In addition, this data collection effort will integrate datasets across the entire transplantation process, encompassing donor organ information, preservation details, post-operative outcomes, survival rates, and, for the first time, post-transplant rejection data.
Stanford Health Care transplant cardiologist and heart transplant research director Kiran Khush said: “This GUARDIAN-Heart sub-study will add data that may prove pivotal for the future of heart transplants.
“Understanding the nuances of post-transplant recovery and the factors influencing patient outcomes will enable us to tailor treatments more effectively.
“Our goal is to reduce complications, lower readmission rates, and ultimately ensure that transplant patients have the best possible quality of life.”
The GUARDIAN study is said to be the largest global post-market observational registry. It tracks over 3,500 organ transplant recipients whose donor organs were preserved and transported using Paragonix Advanced Organ Preservation Systems.
In June, Paragonix Technologies commercially launched its PancreasPak organ preservation system to protect and monitor donor pancreases during transportation.
GUARDIAN has collected millions of data points on clinical outcomes, post-transplant complications, and patient survival to advance the understanding and management of organ transplant care.
The new molecular diagnostics sub-study will enable GUARDIAN investigators to collect detailed data on rejection and readmission rates over 12 months following heart transplants.
Furthermore, the expansion builds on existing data from the pre-operative through discharge phases, extending into the critical post-discharge period.
The study will gather insights through biopsies, cell-free DNA (cfDNA), gene expression profiling (GEP), Molecular Microscope Diagnostic System (MMDx), renal replacement therapy (RRT), and readmission interventions.
Paragonix Technologies CEO Lisa Anderson said: “We thank GUARDIAN Clinical Investigators and our transplant partners for initiating this new study to provide deeper insights into the long-term outcomes of transplant patients.
“The planned analyses will provide data to better understand the impact of preservation on organ rejection and improve post-transplant care for patients.”
