Insight Molecular Diagnostics outlines $1B transplant testing market expansion as company nears FDA submission [Seeking Alpha]
Insight Molecular Diagnostics Inc. (IMDX)
Company Research
Source: Seeking Alpha
CEO Joshua Riggs highlighted that Insight Molecular Diagnostics is nearing a transformative milestone, stating, "In 2026, with the expected FDA authorization of GraftAssureDx, this is going to change" the landscape for transplant patient Quick Insights Ongoing U.S. government shutdown pauses new FDA submissions, introducing uncertainty; management remains confident but acknowledges submission could be delayed if disruptions persist. Management estimates a market exceeding $1 billion, based on 1.5 million managed patients and Medicare reimbursed prices, driven by emerging demand for in-house transplant testing and additional heart and lung assays in future years. Cash burn was held below $6 million in Q3 but is expected to rise due to regulatory and trial costs; management reports ample cash on hand and readiness to reduce expenses if needed, projecting sequentially flat cost trends beyond FDA activities. Recommended For You More Trending News
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- Oncocyte (NASDAQ:IMDX) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Oncocyte (NASDAQ:IMDX) is now covered by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>. They set a "sell (d-)" rating on the stock.MarketBeat
- Oncocyte (NASDAQ:IMDX) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=IMDX&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> tMarketBeat
- Insight Molecular Diagnostics: GraftAssureDX FDA Submission Warrants Hold Rating [Seeking Alpha]Seeking Alpha
- This Biotech Stock Is Up 158% in a Year. What's Driving It Higher? [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