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Favorable Medicare Coverage Decision Supports Commercial Adoption of iMDx GraftAssure Assay Portfolio

IMDX
  • Medicare issued a new Local Coverage Determination (LCD) via MolDX expanding reimbursement for donor-derived cell-free DNA (dd-cfDNA) testing in transplant care.
  • The policy establishes a recurring testing baseline for long-term surveillance, providing clarity for hospitals, physicians, and laboratories.
  • Reimbursement frequency increased for Year 1 kidney transplant surveillance from four tests to six tests annually, while heart transplant testing remains at twelve tests per year.
  • Testing frequency for Years 2 and 3 doubled from two tests per year to four tests per year for both kidney and heart transplant patients.
  • The policy removes the annual testing ceiling for Years 4 and beyond, allowing continued testing if clinical utility is demonstrated.
  • iMDx's GraftAssureCore lab-developed test retains a Medicare reimbursement rate of $2,753 per result, with plans to extend this rate to GraftAssureDx kits after FDA authorization.
  • The final policy cites iMDx-affiliated research, affirming the company's scientific leadership in the industry.
  • iMDx aims to commercialize GraftAssureDx kits to enable in-house testing at transplant centers, supporting a shift from centralized reference laboratories to local facilities.
  • iMDx's immediate product focus is kidney transplant testing, followed by heart transplant testing.
  • The company cites the policy expansion as a key driver for its $2 billion total addressable market for kitted transplant rejection monitoring.