{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-146510","form_type":"8-K","ticker":"GH","cik":"0001576280","company_name":"Guardant Health, Inc.","filed_at":"2024-05-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.044698+00:00","generated_at":"2026-06-01T08:42:58.582533+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA advisory panel strongly recommends approval of Guardant's Shield blood test for CRC screening","bullets":["FDA advisory panel voted 8-1 that Shield is safe, 6-3 that it is effective, and 7-2 that benefits outweigh risks.","Shield blood test showed 83% sensitivity for colorectal cancer detection and 90% specificity for advanced neoplasia in ECLIPSE study.","FDA decision on premarket approval expected later in 2024; Shield is on track to become first FDA-approved blood test for CRC screening.","Approximately 50 million eligible Americans are not up-to-date with CRC screening; Shield offers a blood-draw alternative to stool-based tests."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-146510","json":"https://secwatch.observer/filing/0001193125-24-146510.json","markdown":"https://secwatch.observer/filing/0001193125-24-146510.md","text":"https://secwatch.observer/filing/0001193125-24-146510.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1576280/000119312524146510/0001193125-24-146510-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1576280/000119312524146510/d843201d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T08:42:58.582533+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"}