iMDx is a molecular diagnostics company focused on transplant rejection testing. Its core product line, the GraftAssure family of assays, measures donor-derived cell-free DNA (dd-cfDNA) — fragments of donor DNA that circulate in a recipient's bloodstream when a transplanted organ is being damaged or rejected. This provides a non-invasive alternative to biopsy for monitoring graft health. iMDx's near-term commercial product is GraftAssureCore, a lab-developed test run at its own CLIA-certified lab in Nashville, reimbursed by Medicare at $2,753 per test. Its primary strategic focus, however, is GraftAssureDx — a kitted in vitro diagnostic designed for transplant centers to run in their own labs. iMDx submitted GraftAssureDx to the FDA in March 2026 targeting a mid-2026 launch, starting with kidney (roughly 85% of the transplant market), followed by heart and lung. The key strategic bet is a "decentralized" kit model: rather than sending samples to a centralized reference lab (as competitors CareDx and Natera do), iMDx sells kits to transplant centers, which run the test in-house, bill payers directly, and capture the reimbursement spread as margin. iMDx uses Bio-Rad's digital PCR platform, which it argues is simpler and more economical at low volumes than the NGS-based approaches used by centralized labs. The company also runs a secondary Laboratory Services business — sequencing and testing for pharma customers — which generates near-term gross profit while the core transplant franchise matures. iMDx also holds early-stage oncology assets (DetermaIO, DetermaCNI), though neither is a near-term commercial priority.