other material
confidence high
sentiment neutral
materiality 0.75
iMDx reports Q2 net loss of $11.3M; FDA issues Additional Information Request for GraftAssureDx
Insight Molecular Diagnostics Inc.
- Q2 2026 revenue ~$239K; gross profit $157K (65.7% margin); net loss $11.3M ($0.31/share); adjusted net loss $8.3M ($0.23/share).
- FDA issued Additional Information Request on GraftAssureDx; company must respond within 180 days; expects one more FDA meeting before Q4.
- Medicare LCD (MolDX, July 16) expands dd-cfDNA surveillance coverage, doubling testing to 4x/yr in years 2-3 post-kidney transplant.
- Head-to-head data published in Clinical Chemistry: 99.2% agreement vs leading NGS competitor; CM-Score doubles PPV to 81% vs 54% benchmark.
- R&D expenses $4.5M (-9% sequentially); company remains pre-revenue awaiting FDA authorization for kitted GraftAssureDx.