iMDx Reports Kidney Transplant Patient Achieved ‘Immune Reset’ with Novel Therapy and GraftAssure Monitoring

• American Journal of Transplantation study positions GraftAssure as potentially essential in managing immunosuppression treatment in kidney transplant patients with certain cancers
• GraftAssure used to help avoid overtreatment and preserve patient’s immune system
• As transplant care evolves to include novel therapies, the need for ongoing molecular diagnostic monitoring should continue to grow
  

NASHVILLE, Tenn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (Nasdaq: IMDX), (iMDx), today 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.

“Though it is just a case report, it clearly underscores that our assay measuring dd-cfDNA functioned as a reliable tool to confirm absence of rejection in a rare clinical scenario,” said iMDx Chief Science Officer Dr. Ekke Schuetz. “As transplant care evolves to include novel immunomodulating therapies, such as CAR-T, we expect that the need for molecular monitoring of sustained treatment effects will continue to grow.”

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 (LDT), 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.