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  "description": "Illustrative steady-state annual model; full adherence; fixed preclinical window; not clinical-trial results.",
  "unit": "per 1,000 people per year; false positives count tests, not unique people",
  "incidence_source": "SEER Explorer observed 2019-2023 rates, all races, age and sex specific",
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    "galleri_sensitivity_by_site": null,
    "galleri_fpr_by_age": null
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          "transported_galleri_detection_pct": 34.74660214968083
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        {
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          "transported_galleri_detection_pct": 34.74660214968083
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        {
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          "transported_galleri_detection_pct": 33.44591519255373
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      "source": "https://www.fda.gov/media/194909/download",
      "interpretation": "Exploratory proposed-assay scenario, not a clinical forecast or a model confidence interval. Age endpoint runs vary all marginal limits together; they are not simultaneous confidence bounds.",
      "profile_source": "Table A5, new primary cancers, pp. 48\u201351",
      "age_fpr_source": "Table A6-1 / A7-1, pp. 52 / 54",
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        {
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        {
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        {
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        {
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        {
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        {
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          "transported_galleri_detection_pct": 34.74660214968083
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        {
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          "transported_galleri_detection_pct": 32.141427324980796
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      "source": "https://www.fda.gov/media/194909/download",
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      "profile_source": "Table A5, new primary cancers, pp. 48\u201351",
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          "transported_galleri_detection_pct": 33.44591519255373
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      "source": "https://www.fda.gov/media/194909/download",
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          "transported_galleri_detection_pct": 33.44591519255373
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      "source": "https://www.fda.gov/media/194909/download",
      "interpretation": "Exploratory proposed-assay scenario, not a clinical forecast or a model confidence interval. Age endpoint runs vary all marginal limits together; they are not simultaneous confidence bounds.",
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          "transported_galleri_detection_pct": 32.14860899900919
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        {
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          "cancers_detected_pct": 36.432988769661875,
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          "transported_galleri_detection_pct": 32.14860899900919
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        {
          "sex": "Male",
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          "cancers_per_1000_year": 19.3298536,
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          "extra_caught_per_1000_year": 4.218093610340901,
          "extra_false_positive_tests_per_1000_year": -64.1947888732945,
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            "Galleri": 2.54974238064
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          "transported_galleri_detection_pct": 32.14860899900919
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        {
          "sex": "Male",
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          "cancers_per_1000_year": 23.38367256,
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          "missed_per_1000_year": 20.857331059792003,
          "cancers_detected_pct": 10.803869639064086,
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          "extra_caught_per_1000_year": 0.0,
          "extra_false_positive_tests_per_1000_year": 0.0,
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
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          "cancers_detected_pct": 37.497211467428116,
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
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          "transported_galleri_detection_pct": 33.068703707758154
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    "fda_nhs_age_fpr_point": {
      "source": "https://www.fda.gov/media/194909/download",
      "interpretation": "Exploratory proposed-assay scenario, not a clinical forecast or a model confidence interval. Age endpoint runs vary all marginal limits together; they are not simultaneous confidence bounds.",
      "profile_source": "Table A5, new primary cancers, pp. 48\u201351",
      "age_fpr_source": "Table A6-1 / A7-1, pp. 52 / 54",
      "fallback_sensitivity": 0.31585365853658537,
      "fallback_rule": "Fewer than five cases, unmatched sites, and residual cancers use the study-wide new-primary sensitivity; assumed, not measured for those sites.",
      "subtype_counts": [
        {
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            20
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          "caught": 49,
          "total": 92,
          "uses_fallback": false
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        {
          "seer_sites": [
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          "caught": 21,
          "total": 110,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            57
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          "caught": 1,
          "total": 2,
          "uses_fallback": true
        },
        {
          "seer_sites": [
            47
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          "caught": 37,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            66
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          "caught": 23,
          "total": 215,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            3
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          "caught": 9,
          "total": 21,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            35
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          "caught": 12,
          "total": 15,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            40,
            38,
            34
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          "caught": 12,
          "total": 31,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            86,
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            92,
            93
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          "caught": 27,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
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          "caught": 12,
          "total": 16,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            89
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          "caught": 6,
          "total": 25,
          "uses_fallback": false
        },
        {
          "seer_sites": [
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          "caught": 5,
          "total": 13,
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        {
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            72
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          "caught": 10,
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        },
        {
          "seer_sites": [
            53
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          "caught": 1,
          "total": 29,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            96,
            97
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          "caught": 1,
          "total": 12,
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        },
        {
          "seer_sites": [
            51
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          "caught": 1,
          "total": 3,
          "uses_fallback": true
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        {
          "seer_sites": [
            17
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          "caught": 17,
          "total": 26,
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        },
        {
          "seer_sites": [
            80
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          "caught": 1,
          "total": 5,
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        },
        {
          "seer_sites": [
            18
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          "caught": 4,
          "total": 7,
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        {
          "seer_sites": [
            58
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          "caught": 5,
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        },
        {
          "seer_sites": [
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          "caught": 0,
          "total": 3,
          "uses_fallback": true
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      ],
      "assumptions": {
        "detectable_years": 1.0,
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        "mammography_sensitivity": 0.869,
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        "cervical_sensitivity": 0.941,
        "cervical_non_cancer_positive_rate": 0.07,
        "cervix_present_fraction": 0.75,
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        "lung_cancer_eligible_fraction": 0.6,
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        "galleri_scale": 0.7631067961165049,
        "galleri_fpr": 0.0026,
        "residual_ccga_sensitivity": 0.508,
        "galleri_flat_sensitivity": null,
        "galleri_sensitivity_by_site": {
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          "72": 0.4166666666666667,
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          "83": 0.46551724137931033,
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          "93": 0.46551724137931033,
          "96": 0.08333333333333333,
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        "galleri_fpr_by_age": {
          "211": 0.0009000000000000341,
          "212": 0.0009000000000000341,
          "213": 0.0021999999999999884,
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          "215": 0.004500000000000028
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      "rows": [
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          "caught_per_1000_year": 6.214279053944901,
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          "cancers_detected_pct": 32.14860899900919,
          "false_positive_tests_per_1000_year": 2.1574743220799886,
          "overlap_caught_lower": 6.214279053944901,
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          "overlap_detected_pct_lower": 32.14860899900919,
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          "extra_caught_per_1000_year": 4.218093610340901,
          "extra_false_positive_tests_per_1000_year": -64.5870569318545,
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            "Galleri": 2.1574743220799886
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          "transported_galleri_detection_pct": 32.14860899900919
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        {
          "sex": "Male",
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          "cancers_per_1000_year": 23.38367256,
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          "missed_per_1000_year": 20.857331059792003,
          "cancers_detected_pct": 10.803869639064086,
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          "extra_false_positive_tests_per_1000_year": 0.0,
          "false_positive_tests_by_modality": {
            "FIT": 59.9069744586,
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
          "sex": "Male",
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          "cancers_per_1000_year": 23.38367256,
          "lung_population_eligible_fraction": 0.12775174007539478,
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          "caught_per_1000_year": 8.768225148674162,
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          "cancers_detected_pct": 37.497211467428116,
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          "extra_false_positive_tests_per_1000_year": 4.394773473480029,
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
          "sex": "Male",
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          "transported_galleri_detection_pct": 33.068703707758154
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    "fda_nhs_age_fpr_lower": {
      "source": "https://www.fda.gov/media/194909/download",
      "interpretation": "Exploratory proposed-assay scenario, not a clinical forecast or a model confidence interval. Age endpoint runs vary all marginal limits together; they are not simultaneous confidence bounds.",
      "profile_source": "Table A5, new primary cancers, pp. 48\u201351",
      "age_fpr_source": "Table A6-1 / A7-1, pp. 52 / 54",
      "fallback_sensitivity": 0.31585365853658537,
      "fallback_rule": "Fewer than five cases, unmatched sites, and residual cancers use the study-wide new-primary sensitivity; assumed, not measured for those sites.",
      "subtype_counts": [
        {
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            20
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          "caught": 49,
          "total": 92,
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        {
          "seer_sites": [
            55
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          "caught": 21,
          "total": 110,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            57
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          "caught": 1,
          "total": 2,
          "uses_fallback": true
        },
        {
          "seer_sites": [
            47
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          "caught": 37,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            66
          ],
          "caught": 23,
          "total": 215,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            3
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          "caught": 9,
          "total": 21,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            35
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          "caught": 12,
          "total": 15,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            40,
            38,
            34
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          "caught": 12,
          "total": 31,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            86,
            83,
            92,
            93
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          "caught": 27,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            61
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          "caught": 12,
          "total": 16,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            89
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          "caught": 6,
          "total": 25,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            71
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          "caught": 5,
          "total": 13,
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        },
        {
          "seer_sites": [
            72
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          "caught": 10,
          "total": 24,
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        },
        {
          "seer_sites": [
            53
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          "caught": 1,
          "total": 29,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            96,
            97
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          "caught": 1,
          "total": 12,
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        },
        {
          "seer_sites": [
            51
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          "caught": 1,
          "total": 3,
          "uses_fallback": true
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        {
          "seer_sites": [
            17
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          "caught": 17,
          "total": 26,
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        },
        {
          "seer_sites": [
            80
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          "caught": 1,
          "total": 5,
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        },
        {
          "seer_sites": [
            18
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          "caught": 4,
          "total": 7,
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        {
          "seer_sites": [
            58
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          "caught": 5,
          "total": 27,
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        },
        {
          "seer_sites": [
            76
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          "caught": 0,
          "total": 3,
          "uses_fallback": true
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      ],
      "assumptions": {
        "detectable_years": 1.0,
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        "mammography_sensitivity": 0.869,
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        "cervical_sensitivity": 0.941,
        "cervical_non_cancer_positive_rate": 0.07,
        "cervix_present_fraction": 0.75,
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        "lung_cancer_eligible_fraction": 0.6,
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        "galleri_scale": 0.7631067961165049,
        "galleri_fpr": 0.0026,
        "residual_ccga_sensitivity": 0.508,
        "galleri_flat_sensitivity": null,
        "galleri_sensitivity_by_site": {
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          "72": 0.4166666666666667,
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          "92": 0.46551724137931033,
          "93": 0.46551724137931033,
          "96": 0.08333333333333333,
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        "galleri_fpr_by_age": {
          "211": 0.0004999999999999716,
          "212": 0.0004999999999999716,
          "213": 0.0009999999999999432,
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          "215": 0.0028000000000000112
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      },
      "rows": [
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          "transported_galleri_detection_pct": 33.63533908073709
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          "false_positive_tests_per_1000_year": 66.58482889131191,
          "overlap_caught_lower": 2.526341500208,
          "overlap_caught_upper": 2.526341500208,
          "overlap_detected_pct_lower": 10.803869639064086,
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          "extra_caught_per_1000_year": 0.0,
          "extra_false_positive_tests_per_1000_year": 0.0,
          "false_positive_tests_by_modality": {
            "FIT": 59.9069744586,
            "Lung CT": 6.677854432711923
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
          "sex": "Male",
          "age": "70-74",
          "age_code": 215,
          "cancers_per_1000_year": 23.38367256,
          "lung_population_eligible_fraction": 0.12775174007539478,
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          "caught_per_1000_year": 8.768225148674162,
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          "cancers_detected_pct": 37.497211467428116,
          "false_positive_tests_per_1000_year": 69.31935460814393,
          "overlap_caught_lower": 8.054222201002224,
          "overlap_caught_upper": 9.516074811091881,
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          "overlap_detected_pct_upper": 40.69538173131125,
          "extra_caught_per_1000_year": 6.241883648466162,
          "extra_false_positive_tests_per_1000_year": 2.7345257168320103,
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            "FIT": 59.9069744586,
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          "transported_galleri_detection_pct": 33.068703707758154
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        {
          "sex": "Male",
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          "lung_population_eligible_fraction": 0.12775174007539478,
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          "cancers_detected_pct": 33.068703707758154,
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          "extra_caught_per_1000_year": 5.2063358946507465,
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            "Galleri": 2.7345257168320107
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          "transported_galleri_detection_pct": 33.068703707758154
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      ]
    },
    "fda_nhs_age_fpr_upper": {
      "source": "https://www.fda.gov/media/194909/download",
      "interpretation": "Exploratory proposed-assay scenario, not a clinical forecast or a model confidence interval. Age endpoint runs vary all marginal limits together; they are not simultaneous confidence bounds.",
      "profile_source": "Table A5, new primary cancers, pp. 48\u201351",
      "age_fpr_source": "Table A6-1 / A7-1, pp. 52 / 54",
      "fallback_sensitivity": 0.31585365853658537,
      "fallback_rule": "Fewer than five cases, unmatched sites, and residual cancers use the study-wide new-primary sensitivity; assumed, not measured for those sites.",
      "subtype_counts": [
        {
          "seer_sites": [
            20
          ],
          "caught": 49,
          "total": 92,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            55
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          "caught": 21,
          "total": 110,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            57
          ],
          "caught": 1,
          "total": 2,
          "uses_fallback": true
        },
        {
          "seer_sites": [
            47
          ],
          "caught": 37,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            66
          ],
          "caught": 23,
          "total": 215,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            3
          ],
          "caught": 9,
          "total": 21,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            35
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          "caught": 12,
          "total": 15,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            40,
            38,
            34
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          "caught": 12,
          "total": 31,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            86,
            83,
            92,
            93
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          "caught": 27,
          "total": 58,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            61
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          "caught": 12,
          "total": 16,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            89
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          "caught": 6,
          "total": 25,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            71
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          "caught": 5,
          "total": 13,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            72
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          "caught": 10,
          "total": 24,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            53
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          "caught": 1,
          "total": 29,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            96,
            97
          ],
          "caught": 1,
          "total": 12,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            51
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          "caught": 1,
          "total": 3,
          "uses_fallback": true
        },
        {
          "seer_sites": [
            17
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          "caught": 17,
          "total": 26,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            80
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          "caught": 1,
          "total": 5,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            18
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          "caught": 4,
          "total": 7,
          "uses_fallback": false
        },
        {
          "seer_sites": [
            58
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          "caught": 5,
          "total": 27,
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        },
        {
          "seer_sites": [
            76
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          "caught": 0,
          "total": 3,
          "uses_fallback": true
        }
      ],
      "assumptions": {
        "detectable_years": 1.0,
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        "galleri_interval": 1.0,
        "mammography_sensitivity": 0.869,
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        "cervical_sensitivity": 0.941,
        "cervical_non_cancer_positive_rate": 0.07,
        "cervix_present_fraction": 0.75,
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        "lung_cancer_eligible_fraction": 0.6,
        "lung_population_eligibility_multiplier": 1.0,
        "galleri_scale": 0.7631067961165049,
        "galleri_fpr": 0.0026,
        "residual_ccga_sensitivity": 0.508,
        "galleri_flat_sensitivity": null,
        "galleri_sensitivity_by_site": {
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          "72": 0.4166666666666667,
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          "83": 0.46551724137931033,
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          "92": 0.46551724137931033,
          "93": 0.46551724137931033,
          "96": 0.08333333333333333,
          "97": 0.08333333333333333,
          "40": 0.3870967741935484,
          "3": 0.42857142857142855,
          "46": 0.31585365853658537,
          "80": 0.2,
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          "18": 0.5714285714285714,
          "17": 0.6538461538461539,
          "61": 0.75,
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        "galleri_fpr_by_age": {
          "211": 0.001700000000000017,
          "212": 0.001700000000000017,
          "213": 0.0048000000000000395,
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          "215": 0.00730000000000004
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      },
      "rows": [
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          "extra_caught_per_1000_year": 6.241883648466162,
          "extra_false_positive_tests_per_1000_year": 7.1292991903120395,
          "false_positive_tests_by_modality": {
            "FIT": 59.9069744586,
            "Lung CT": 6.677854432711923,
            "Galleri": 7.129299190312039
          },
          "transported_galleri_detection_pct": 33.068703707758154
        },
        {
          "sex": "Male",
          "age": "70-74",
          "age_code": 215,
          "cancers_per_1000_year": 23.38367256,
          "lung_population_eligible_fraction": 0.12775174007539478,
          "cervical_age_eligible_fraction": 0,
          "residual_cancers_per_1000_year": 1.5784580600000027,
          "policy": "Galleri alone",
          "caught_per_1000_year": 7.732677394858746,
          "missed_per_1000_year": 15.650995165141254,
          "cancers_detected_pct": 33.068703707758154,
          "false_positive_tests_per_1000_year": 7.129299190312039,
          "overlap_caught_lower": 7.732677394858746,
          "overlap_caught_upper": 7.732677394858746,
          "overlap_detected_pct_lower": 33.068703707758154,
          "overlap_detected_pct_upper": 33.068703707758154,
          "extra_caught_per_1000_year": 5.2063358946507465,
          "extra_false_positive_tests_per_1000_year": -59.455529700999875,
          "false_positive_tests_by_modality": {
            "Galleri": 7.129299190312039
          },
          "transported_galleri_detection_pct": 33.068703707758154
        }
      ]
    }
  }
}
