{
  "docId": "019dd923-622c-750b-8b98-0c85e40ec39b",
  "docSlug": "9b248b07037e",
  "documentTitle": "CareDx, Inc. (CDNA)",
  "authorId": "53_Kerrisdale_Capital",
  "authorName": "Kerrisdale Capital",
  "documentKindSlug": "research-note",
  "documentKindLabel": "Research note",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2019-07-01 00:00:00",
  "orientation": "portrait",
  "aspectRatio": 0.77272725,
  "pageNumber": 4,
  "pageCount": 29,
  "prevPage": 3,
  "nextPage": 5,
  "slideType": "research-note",
  "function": "diagnose_problem",
  "density": "overcrowded",
  "nDataPoints": 3,
  "notes": "The slide argues that AlloSure has high false negative rates for subclinical rejection and that its commercial success is driven by regulatory loopholes rather than clinical utility.",
  "elementsJson": [
    "paragraph",
    "footnote"
  ],
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b98-0c85e40ec39b/4",
  "deckHref": "/decks/019dd923-622c-750b-8b98-0c85e40ec39b",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b98-0c85e40ec39b.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b98-0c85e40ec39b#slide-4",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "In other words, AlloSure misses the overwhelming majority of subclinical rejection episodes, and that’s ignoring the false positives in that 3.9% number.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-203e-77ad-a69c-63b34be2d9a8",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.07,
        "w": 0.78,
        "x": 0.11,
        "y": 0.15
      },
      "kind": "paragraph",
      "text": "What about subclinical rejection, which goes undetected by creatinine measurement? In CareDx's DART clinical trial, only 3.9% of a reference cohort of patients who exhibited no signs of impaired kidney function tested positive for kidney rejection using AlloSure.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "1590d0dd-ba9f-4939-b933-9c5b384f5183",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.07,
        "w": 0.78,
        "x": 0.11,
        "y": 0.29
      },
      "kind": "paragraph",
      "text": "More recent studies confirm the problems with AlloSure implicit in the DART trial and cast further doubt on the accuracy of the test, strongly suggesting that AlloSure is structurally incapable of identifying T-Cell-Mediated Rejection (TCMR).",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "25351198-d677-42ef-b5f6-d24650dbc976",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.04,
        "w": 0.78,
        "x": 0.11,
        "y": 0.09
      },
      "kind": "paragraph",
      "text": "rejection (high false positive rate), but AlloSure presents the much more severe problem of underdiagnosing rejection (high false negative rate).",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "72553103-5758-45d3-b362-0dcd451cdf87",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.06,
        "w": 0.78,
        "x": 0.11,
        "y": 0.38
      },
      "kind": "paragraph",
      "text": "AlloSure's commercial success is unsustainably built on collapsing clinical-study usage and conditional Medicare coverage. If AlloSure is such a poor biomarker, how did it reach a ~$45 million annual revenue run rate in less than 18 months?",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "794dcbc7-6a05-4071-abc5-b732fdb211a5",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.06,
        "w": 0.78,
        "x": 0.11,
        "y": 0.22
      },
      "kind": "paragraph",
      "text": "But studies documenting the results of surveillance biopsies reveal that the subclinical rejection rate ranges from 15-35%. In other words, AlloSure misses the overwhelming majority of subclinical rejection episodes.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "89a77f64-5154-4ea7-8b58-e419b0ab7ef3",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.11,
        "w": 0.78,
        "x": 0.11,
        "y": 0.52
      },
      "kind": "paragraph",
      "text": "MolDX, short for Molecular Diagnostic Services, is a program run by Palmetto GBA... To get a Local Coverage Determination (LCD) from MolDX, a test must pass a technical assessment.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "8a218b43-c44e-43dd-a3ec-bf1182a31d30",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "CareDx can technically claim that AlloSure is “more accurate” than serum creatinine measurement because it has a lower rate of false positives. But accuracy is not the goal of rejection testing, rather, detecting rejection is. — Footnote 2",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-203e-77ad-a69c-66bfafbd07e6",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.04,
        "w": 0.78,
        "x": 0.11,
        "y": 0.85
      },
      "kind": "source-note",
      "text": "CareDx can technically claim that AlloSure is “more accurate” than serum creatinine measurement because it has a lower rate of false positives. But accuracy is not the goal of rejection testing, rather, detecting rejection is.",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "807d7837-db30-4c30-855f-7eb88091bec4",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.78,
        "x": 0.11,
        "y": 0.89
      },
      "kind": "source-note",
      "text": "Bromberg JS, Brennan DC, Poggio E, et al. Biological Variation of Donor-Derived Cell-Free DNA in Renal Transplant Recipients: Clinical Implications. J Appl Lab Med 2017; 2:309",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "dfd607ff-1580-4b2d-aacc-dbe766ec7517",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [],
  "arcBeats": [],
  "loops": [
    {
      "to": 26,
      "from": 4,
      "name": "Cost Of Inaction",
      "slug": "27-cost-of-inaction",
      "bestFor": "Urgent budget requests, compliance, risk mitigation",
      "matchId": "6ece1bb9-6dc2-4b36-a983-1e6b3a2a754d",
      "evidence": "The document emphasizes the risks of not acting on AlloSure's ineffectiveness",
      "position": 0,
      "objective": "Highlight the cost of inaction for investors",
      "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point",
      "confidence": 0.7,
      "description": "Quantify what happens if the audience does nothing"
    }
  ],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}