{"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","discovered_at":"2026-08-10T20:12:01.530848+00:00","generated_at":"2026-08-10T20:12:51.614870+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"iMDx reports Q2 net loss of $11.3M; FDA issues Additional Information Request for GraftAssureDx","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-036863","json":"https://secwatch.observer/filing/0001493152-26-036863.json","markdown":"https://secwatch.observer/filing/0001493152-26-036863.md","text":"https://secwatch.observer/filing/0001493152-26-036863.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-10T20:12:51.614870+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}