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The Real-life Experience of Developing and Commercializing TruGraf, a Validated Non-Invasive Transplant Biomarker
  • +2
  • Martin First,
  • Steven Kleiboeker,
  • Stanley Rose,
  • John Friedewald,
  • Michael Abecassis
Martin First
Transplant Genomics Inc.
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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.

Peer review status:POSTED

17 Apr 2020Submitted to Biotechnology Journal
24 Apr 2020Assigned to Editor
24 Apr 2020Submission Checks Completed