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The Real-life Experience of Developing and Commercializing TruGraf, a Validated Non-Invasive Transplant Biomarker
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  • Martin First,
  • Steven Kleiboeker,
  • Stanley Rose,
  • John Friedewald,
  • Michael Abecassis
Martin First
Transplant Genomics Inc.

Corresponding Author:[email protected]

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Steven Kleiboeker
Eurofins Viracor Inc
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Stanley Rose
Transplant Genomics Inc.
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John Friedewald
Northwestern University Feinberg School of Medicine
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Michael Abecassis
University of Arizona College of Medicine
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Abstract

Despite improvement in short-term outcomes, long-term results for kidney transplant recipients remain suboptimal. Immunological rejection is a leading cause of graft failure and recent research points to undetected “silent” subclinical acute rejection as a key component of this problem. While biopsies remain the gold-standard method for detecting silent rejection, non-invasive methods offer significant advantages especially in terms of patient safety and for serial monitoring of stable patients. This manuscript details the real-life challenges involved in the ultimately successful development and commercialization of TruGraf, a clinically validated, blood-based gene expression assay that offers the potential to reduce the use of surveillance (protocol) biopsies in renal transplant recipients with stable renal function.
17 Apr 2020Submitted to Biotechnology Journal
24 Apr 2020Submission Checks Completed
24 Apr 2020Assigned to Editor