{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-186674","form_type":"8-K","ticker":"GH","cik":"0001576280","company_name":"Guardant Health, Inc.","filed_at":"2024-07-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.603772+00:00","generated_at":"2026-05-31T15:43:21.145435+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Guardant Health's Shield blood test gets FDA approval for colorectal cancer screening in ages 45+","bullets":["Shield is first blood test approved by FDA as a primary screening option for colorectal cancer.","Meets CMS requirements for Medicare coverage; expected to be covered for eligible Medicare beneficiaries.","ECLIPSE study showed 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia.","Real-world adherence rate for Shield is over 90%, compared to 28-71% for other screening methods.","Company to launch test soon; commercial insurance coverage expected after future guideline inclusion."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-186674","json":"https://secwatch.observer/filing/0001193125-24-186674.json","markdown":"https://secwatch.observer/filing/0001193125-24-186674.md","text":"https://secwatch.observer/filing/0001193125-24-186674.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1576280/000119312524186674/0001193125-24-186674-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1576280/000119312524186674/d869952d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T15:43:21.145435+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"}