{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-21",
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      "street_1": "505 Penobscot Dr.",
      "street_2": "",
      "city": "Redwood City",
      "state": "CA",
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      "generic_name": "Next generation sequencing oncology panel, somatic or germline variant detection system",
      "trade_name": "Guardant360 CDx",
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      "advisory_committee": "PA",
      "advisory_committee_description": "Pathology",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
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      "date_received": "2026-03-12",
      "decision_date": "2026-09-18",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "Approval for expanding the intended use and indications for use of Guardant360 CDx to include a companion diagnostic indication for the detection of ESR1 mutations in Breast Cancer (BC) patients who may benefit from treatment with INLURIYO (imlunestrant) in combination with VERZENIO (abemaciclib).",
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}