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  "docSlug": "9b248b07037e",
  "documentTitle": "CareDx, Inc. (CDNA)",
  "authorId": "53_Kerrisdale_Capital",
  "authorName": "Kerrisdale Capital",
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  "presentationDate": "2019-07-01 00:00:00",
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  "nDataPoints": 16,
  "notes": "The slide uses data to challenge the clinical utility and market size of the AlloSure test.",
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      "kind": "callout",
      "text": "Which begs the question – why perform a $2800 AlloSure test when it will miss over half the cases identified by a $755 DSA blood test?",
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      "kind": "metric",
      "text": "AlloSure Hit Rate: 43%",
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      "kind": "paragraph",
      "text": "In a more recent presentation by the group at the University of Colorado at the American Transplant Congress, a different set of results was presented. The sample set in this study was composed of 70 biopsies performed on patients whose blood tests came back positive for DSA, indicating risk of AMR. Of these, 39 biopsies were diagnosed as AMR. Not all the DSA tests were paired with an AlloSure test, but in those that were, AlloSure correctly identified only 43% of rejection cases. Which begs the question – why perform a $2800 AlloSure test when it will miss over half the cases identified by a $755 DSA blood test?",
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      "text": "To summarize: AlloSure is anatomically incapable of detecting the most common form of kidney rejection, TCMR, even in the presence of impaired kidney function. In the case of AMR, it's impossible for AlloSure to be used as a rule-out mechanism in the presence of impaired kidney function or a positive DSA test, so a $2 billion market opportunity built on mass AlloSure screening is, at best, a delusion. Finally, it's almost certain that AlloSure cannot identify subclinical AMR in any systematic way, though it's worth noting that the market for AMR screening is comprised of highly sensitized transplant recipients, which represent – at most – about 15% of the total kidney transplant population.",
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      "kind": "paragraph",
      "text": "Imagine spending $1.4 million on AlloSure tests in the span of 8 months and finding only one incremental case of rejection that's potentially just statistical randomness (in cfDNA sampling).",
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      "kind": "source-note",
      "text": "Source: AST Transplantation Summit Program Guide, Abstract #40",
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      "kind": "source-note",
      "text": "23 Based on the granular data reported by the Organ Procurement and Transplantation Network",
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      "kind": "table",
      "text": "Reason for Biopsy | Sample Size | Biopsy-Diagnosed Rejections | Positive AlloSure Tests | AlloSure Hit Rate",
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      "kind": "title",
      "text": "Distribution of Donor-Derived Cell-Free DNA Percentage by Biopsy Diagnosis",
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      "name": "Cost Of Inaction",
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      "evidence": "The document emphasizes the risks of not acting on AlloSure's ineffectiveness",
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