Insight Molecular Outlines Commercial Gains, FDA De Novo Submission Plans For GraftAssureDx In 2026

• GraftAssure™ technology adoption further broadens with 20 global transplant centers engaged by year-end 2025, including first Canadian site
• GraftAssureDx™ FDA IVD approval application 95% complete at year-end; expect full submission in coming weeks
• Accelerating planned UK CE mark and EU IVDR submission to first half 2026, following successful TÜV SÜD ISO 13485 stage 1 & 2 audit completions in Q4 2025
• Strong engagement from clinical community on GraftAssureCore™ kidney registry with 17 U.S. transplant centers now planning to send samples in 2026
• Management to be in San Francisco for meetings during "JPM Week," January 12 to 15, 2026
   

NASHVILLE, Tenn., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., (NASDAQ:IMDX), (iMDx), today provided a year-end business update regarding its commercial progress, its GraftAssureDx™ test kit clinical trial and planned in vitro diagnostic (IVD) de novo submission to the United States Food & Drug Administration (FDA), as well as its plans for additional regulatory submissions and registry study progress in 2026.