---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-036863"
form_type: "8-K"
ticker: "IMDX"
cik: "0001642380"
company_name: "Insight Molecular Diagnostics Inc."
filed_at: "2026-08-10T20:10:27+00:00"
generated_at: "2026-08-10T20:12:51.614870+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# iMDx reports Q2 net loss of $11.3M; FDA issues Additional Information Request for GraftAssureDx

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-26-036863
- form_type: 8-K
- ticker: IMDX
- cik: 0001642380
- company_name: Insight Molecular Diagnostics Inc.
- filed_at: 2026-08-10T20:10:27+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1642380/000149315226036863/0001493152-26-036863-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1642380/000149315226036863/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-036863
- JSON: https://secwatch.observer/filing/0001493152-26-036863.json
- Plain text: https://secwatch.observer/filing/0001493152-26-036863.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.