iMDx kidney transplant test featured in Lancet study, gets Medicare nod

Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) highlighted a study published in The Lancet Regional Health – Europe that examined the use of its GraftAssure donor-derived cell-free DNA (dd-cfDNA) testing technology to guide treatment decisions for kidney transplant patients experiencing antibody-mediated rejection (AMR).

The study is an extension of a Phase 2 felzartamab trial published in the New England Journal of Medicine in 2024, which also used GraftAssure testing. In that earlier study, researchers reported that CD38-targeted therapy may offer an approach to treating AMR, and that dd-cfDNA testing helped demonstrate therapeutic efficacy. Clinicians subsequently continued monitoring patients using GraftAssure to detect AMR recurrence and guide repeat treatment.

According to iMDx Chief Science Officer Prof. Dr. Ekkehard Schuetz, "the use of our dd-cfDNA test resulted in sparing roughly two-thirds of the drug compared to unguided administration every four weeks, which is economically beneficial and reduces the number of patient hospital visits required for drug infusion." He noted caution in interpreting findings from small cohort studies.

The company also announced it received confirmation of Medicare reimbursement coverage from MolDX, a Centers for Medicare & Medicaid Services program, for kidney transplant rejection treatment response monitoring using dd-cfDNA testing. iMDx said this coverage applies to the monitoring use case described in the Lancet study and was received separately from a previously announced broader Medicare coverage decision for its GraftAssure assay portfolio.

The Lancet study used GraftAssureCore, iMDx's laboratory-developed test performed at its CLIA-certified facility in Franklin, Tennessee. The company also sells research-use-only test kits and is seeking FDA marketing authorization for GraftAssureDx, a kit intended for clinical use that remains under FDA review.

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