Insight Molecular Diagnostics outlines transplant testing strategy in investor presentation - IMDX News | RalliesInsight Molecular Diagnostics outlines transplant testing strategy in investor presentation
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IMDX• Investor presentation highlights transplant testing plan
- Insight Molecular Diagnostics investor presentation outlined a strategy to decentralize molecular diagnostics by selling kitted assays for in-house hospital lab testing.
- Transplant rejection testing positioned as the near-term priority, centered on the GraftAssureDx program, with RUO kits launched in 2024.
- FDA IVD submission for clinical use filed in March 2026; FDA clearance for kidney on Bio-Rad’s QX600Dx targeted in 2026.
- Medicare reimbursement cited at $2,753 per result for GraftAssureCore under CPT 81479 and DEX Z-code Z0507.
- Management estimated regulated transplant testing as a ~$3B global opportunity, with U.S. kidney baseline TAM at $500 million.
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