IMDX Submits GraftAssureDx for FDA Review and Reports Q4 2025 Results
Insight Molecular Diagnostics Inc. (IMDX)
Company Research
Source: GlobeNewswire
Submitted GraftAssureDx™ for kidney transplant rejection testing for FDA review on Wednesday, March 25Welcomed second favorable head-to-head data set from an independent study at large hospital comparing GraftAssure to a leading centralized transplant rejection testExpect U.K. CE marking via self-certification in Q2 2026Completed $26 million financing in February; funds intended to support expansion into heart transplantation market while also commercializing testing for kidney NASHVILLE, Tenn., March 26, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., iMDx, (Nasdaq: IMDX), today published the following letter to shareholders in conjunction with its fourth quarter results: Fellow shareholders, We are pleased to share that GraftAssureDx has become, to our knowledge, the first ever kitted dd-cfDNA assay to be submitted to the FDA for regulatory review. Our FDA submission this week represents the culmination of 12 years of clinical development and three years of highly
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News
- Insight Molecular Diagnostics Inc. (IMDX) Q4 2025 Earnings Call Transcript [Seeking Alpha]Seeking Alpha
- IMDX Submits GraftAssureDx for FDA Review and Reports Q4 2025 Results [Yahoo! Finance]Yahoo! Finance
- Insight Molecular Diagnostics Inc. Q4 2025 Earnings Preview [Seeking Alpha]Seeking Alpha
- iMDx to Release Fourth Quarter 2025 Results on March 26, 2026 and Attend Needham Virtual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- iMDx to Release Fourth Quarter 2025 Results on March 26, 2026 and Attend Needham Virtual Healthcare ConferenceGlobeNewswire
IMDX
Sec Filings
- 3/26/26 - Form 10-K
- 3/26/26 - Form 8-K
- 2/26/26 - Form 8-K
- IMDX's page on the SEC website