iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion [Yahoo! Finance]
Insight Molecular Diagnostics Inc. (IMDX)
Company Research
Source: Yahoo! Finance
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. “We are very excited about 2026 and being on the
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News
- Insight ‘congratulated' STAR working group on organ health testing paper [Yahoo! Finance]Yahoo! Finance
- IMDX Supports AST and ASHI STAR Working Group’s Call for Decentralized Transplant MonitoringGlobeNewswire
- iMDx Announces “JPM Week” and “BTIG Snowbird” Conference Participation [Yahoo! Finance]Yahoo! Finance
- iMDx Announces “JPM Week” and “BTIG Snowbird” Conference ParticipationGlobeNewswire
- iMDx to Welcome Industry Veteran as Vice President of Medical Affairs to Prepare for Commercial Transplant Assay Launch [Yahoo! Finance]Yahoo! Finance
IMDX
Sec Filings
- 11/10/25 - Form 10-Q
- 11/10/25 - Form 8-K
- 11/4/25 - Form 4
- IMDX's page on the SEC website