Insight Molecular says kidney transplant patient achieved ‘immune reset’

Insight Molecular Diagnostics (IMDX) announced results from a study conducted by iMDx researchers and partners published in the American Journal of Transplantation, that demonstrated the value of its GraftAssure assay for long-term monitoring of a kidney transplant patient with severe complications requiring novel therapy. The study reports a unique case in which a 33-year-old transplant patient developed a type of lymphoma, necessitating the cessation of traditional immunosuppression for treatment. GraftAssure molecular testing proved essential for confirming the absence of transplanted organ rejection throughout the patient’s treatment period with novel CD19 CAR-T therapy. Remarkably, the patient maintained stable graft function for about two years without immunosuppression and stayed in remission, suggesting an “immune reset” because of treatment. The company believes that this study adds to a body of research that may position GraftAssure as potentially essential in managing kidney transplant patients, and points to growing clinical use cases over time. The GraftAssure family of assays represent iMDx’s flagship technology. The assay family includes GraftAssureCore, the company’s laboratory-developed test, currently reimbursed by Medicare and performed at its CLIA-certified laboratory in Nashville. GraftAssureIQ became available for purchase in summer 2024 for research use only, while GraftAssureDx is in development as a clinical molecular diagnostic test kit, which can be distributed to hospitals to expand and improve testing access for kidney transplant patients. The company expects that the clinical kitted version of its assay will deliver new value in the estimated $1 billion addressable market for kitted transplant rejection testing. As referenced by Dr. Schuetz above, GraftAssure tests measure an established biomarker of transplant rejection, known as donor-derived cell-free DNA, or dd-cfDNA. Post-transplantation lymphoproliferative disorder is a type of lymphoma that can develop as a result of immunosuppression. The treatment for PTLD itself requires a robust immune response, which introduces a challenge for transplant patients who are given immunosuppressive regimens to prevent organ rejection. In the case of the 33-year-old patient in this study who developed PTLD, CD19 chimeric antigen receptor T-cell therapy, a type of immunotherapy designed to genetically engineer the patient’s T-cells to fight the infected tumor cells, was administered as a fourth-line treatment after three previous treatments had failed or stopped working. In the reported case, longitudinal monitoring using dd-cfDNA to confirm non-rejection allowed for successful CAR-T treatment, resulting in sustained graft health as monitored by dd-cfDNA, and oncological remission until month 23 of the observation period. This suggested a potential “immune reset”, a sign of successful treatment, which is an unexpected finding for a transplant patient generally reliant on immunosuppressive medication to prevent organ rejection. By nature, suppressing the immune system to prevent organ rejection can result in the development of certain cancers in transplant patients. This case exemplifies that non-invasive biomarkers such as dd-cfDNA measured by GraftAssure to monitor for organ rejection during and after therapy is instrumental to guide therapy.