{"schema_version":"secwatch.filing_event.v1","accession":"0001116463-26-000046","form_type":"8-K","ticker":"OSUR","cik":"0001116463","company_name":"ORASURE TECHNOLOGIES INC","filed_at":"2026-06-11T13:02:10+00:00","discovered_at":"2026-06-11T13:03:00.288186+00:00","generated_at":"2026-06-11T13:03:10.433436+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"OraSure receives FDA clearance for Colli-Pee Dx urine collection kit for STI tests on Roche systems","bullets":["FDA clearance covers Colli-Pee Dx kit for use with Roche cobas 5800/6800/8800 systems for CT, NG, TV, MG pathogens.","Kit enables at-home self-collection of first-void urine for both male and female patients.","Subsidiary DNA Genotek's product expands OraSure's at-home diagnostics portfolio."],"urls":{"canonical":"https://secwatch.observer/filing/0001116463-26-000046","json":"https://secwatch.observer/filing/0001116463-26-000046.json","markdown":"https://secwatch.observer/filing/0001116463-26-000046.md","text":"https://secwatch.observer/filing/0001116463-26-000046.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1116463/000111646326000046/0001116463-26-000046-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1116463/000111646326000046/osur-20260611.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-11T13:03:10.433436+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"}