iMDx and ASTS award grant for dd-cfDNA testing health economics study
Insight Molecular Diagnostics Inc. and the American Society of Transplant Surgeons awarded a $100,000 grant to Drs. Kenneth Andreoni and Kenneth Chavin to research the health economics of in-house versus send-out dd-cfDNA testing in kidney transplantation. The study will compare costs and clinical outcomes to support the commercialization of iMDx's GraftAssureDx, which is currently under FDA review.

*this image is generated using AI for illustrative purposes only.
Insight Molecular Diagnostics Inc. and the American Society of Transplant Surgeons (ASTS) announced the recipients of the ASTS-iMDx Health Economics Research Grant on June 22, 2026. Dr. Kenneth Andreoni of Thomas Jefferson University and Dr. Kenneth Chavin of Temple Health received the $100,000 grant to study the health economics of in-house versus send-out donor-derived cell-free DNA (dd-cfDNA) testing in kidney transplantation. The research aims to provide rigorous economic and outcomes data to guide transplant programs in laboratory infrastructure and assay selection decisions.
The grant will fund an independent econometric study comparing costs, clinical impact, and operational implications of in-house diagnostic testing against centralized laboratory testing. Results are expected to support commercialization planning for GraftAssureDx, which is currently under FDA review. ASTS and iMDx established the grant to analyze total cost of care, return on investment, clinical outcomes, and operational efficiency, utilizing advanced econometric modeling such as Markov models or decision-tree analysis.
Grant Recipients and Objectives
Dr. Andreoni serves as Surgical Director of Kidney Transplantation at Thomas Jefferson University, while Dr. Chavin holds appointments at Temple Health. Together, they bring expertise in transplant surgery, health systems management, and clinical research. The project seeks to develop a rigorous economic model to help transplant centers evaluate the true costs and benefits of in-house testing, which has the potential to improve turnaround times and patient care.
GraftAssure Product Portfolio
iMDx's GraftAssure technology quantifies dd-cfDNA, a biomarker of kidney transplant rejection validated in peer-reviewed studies. The company's transplant diagnostics include the following products:
| Product | Description |
|---|---|
| GraftAssureCore | Laboratory-developed test (LDT), currently reimbursed by CMS and performed at iMDx's CLIA-certified laboratory in Franklin, Tenn. |
| GraftAssureIQ | Research-use-only (RUO) kit intended and labeled for non-clinical applications. |
| GraftAssureDx | In vitro diagnostic (IVD) kit submitted to the FDA for regulatory review under the Class II de novo pathway. |
iMDx is seeking FDA marketing authorization for GraftAssureDx to sell the kit to transplant centers in the U.S., aiming to deliver faster, affordable tests for in-house use.
What is the expected timeline for the FDA's decision on the Class II de novo submission for GraftAssureDx?
How might the study's findings influence CMS reimbursement policies for in-house versus centralized dd-cfDNA testing?
What market share does iMDx anticipate capturing for GraftAssureDx if FDA authorization is granted?
























