Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission
Insight Molecular Diagnostics Inc. (IMDX)
Company Research
Source: GlobeNewswire
Three-site reproducibility study completed by Tampa General Hospital, Mayo Clinic, and Baylor Scott & White HealthSufficient clinical samples collected to support statistical analysis and FDA submissionCompany achieved final ISO 13485 certification on Feb. 26, enabling U.K. and E.U. regulatory submissions NASHVILLE, Tenn., March 03, 2026 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc. (Nasdaq: IMDX) (“iMDx”) today announced that in February the company completed several major milestones to support the GraftAssureDx™ test kit clinical trial for its planned in vitro diagnostic (IVD) De Novo submission to the U.S. Food and Drug Administration (FDA) and also received its ISO 13485 certification. Beginning in 2026, iMDx seeks to deliver the industry-leading molecular diagnostic test kit for clinical use that expands and improves access to organ health testing for kidney transplant patients. The company expects that enabling localized testing will deliver new value in the roughly
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News
- Insight Molecular Diagnostics Completes Key Milestones Advancing GraftAssureDx Toward FDA Submission [Yahoo! Finance]Yahoo! Finance
- How Insight Molecular Diagnostics (IMDX) Story Is Shifting With New Funding And GraftAssureDx Catalyst [Yahoo! Finance]Yahoo! Finance
- Oncocyte (NASDAQ:IMDX) had its price target raised by analysts at Lake Street Capital from $8.00 to $12.00. They now have a "buy" rating on the stock.MarketBeat
- iMDx Announces $26.0 Million Registered Direct OfferingGlobeNewswire
- Insight ‘congratulated' STAR working group on organ health testing paper [Yahoo! Finance]Yahoo! Finance
IMDX
Sec Filings
- 2/26/26 - Form 8-K
- 2/12/26 - Form SCHEDULE
- 2/12/26 - Form 4
- IMDX's page on the SEC website