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  "docSlug": "9b248b07037e",
  "documentTitle": "CareDx, Inc. (CDNA)",
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  "presentationDate": "2019-07-01 00:00:00",
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      "text": "In our view, the total failure of AlloSure in the context of TCMR makes CareDx's recommended testing protocol a non-starter for Medicare, particularly considering that it would increase Medicare expenditures on transplant patients by 25% if implemented broadly.",
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      "text": "The trial results will also have regulatory implications. As the MolDX LCD implies, the use case boundaries defined by the KOAR trial results will determine the eventual Medicare coverage of AlloSure. In our view, the total failure of AlloSure in the context of TCMR makes CareDx's recommended testing protocol a non-starter for Medicare, particularly considering that it would increase Medicare expenditures on transplant patients by 25% if implemented broadly. The entire point of broad MolDX coverage was to allow for the testing of clinical utility, and when that testing definitively comes up empty, the coverage will be rapidly scaled back. We expect that Medicare will eventually cover dd-cfDNA in cases of AMR or suspected AMR. That would be the death knell for AlloSure, but it looks like attrition and competition will get there first.",
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      "text": "recipients by administering AlloSure tests is a legitimate possibility. Even in the absence of poor trial results and massive attrition, that proposition seems ridiculous.",
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      "text": "But those trial results are important in quantifying the realistic TAM for AlloSure because they clarify the potential use cases for dd-cfDNA. It's pretty clear that AlloSure can't be used to detect or rule out rejection when used as a screening test, so estimating a TAM based upon its use in that capacity – as CareDx does – is fanciful. Given the potential utility of cfDNA in the context of AMR, the two use cases discussed previously – AMR monitoring and, much more speculatively, AMR screening – amount to a TAM of ~$500 million in the best case. Even that – at 25% of CareDx's estimate – is doubtful: AMR screening is likely to wind up the domain of genomic tests like TruGraf that – unlike AlloSure – are sensitive to subclinical AMR, and the price tag on dd-cfDNA is almost certain to decline.",
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