Laboratory Testing for Transplantation Rejection 2.02.55
Summary
Gene expression profiling (AlloMap) is considered medically appropriate for the management of individuals after heart transplantation when the individual is age 15 years or older, is 55 days to five years post-transplant, and has stable heart allograft function, including no signs or symptoms of congestive heart failure, a current echocardiogram with left ventricular ejection fraction of at least 45%, no severe cardiac allograft vasculopathy, no more than one episode of moderate or severe cellular rejection within the past year, and no history or evidence of antibody mediated rejection with associated hemodynamic compromise. Measurement of donor-derived cell-free DNA (e.g., AlloSure, myTAIHEART, Prospera, Viracor TRAC, Clarava, Tuteva) and of donor and third party-induced CD154+ T-cytotoxic memory cells (e.g., Pleximark) are considered investigational for the management of individuals after organ transplantation, including detection of acute transplant rejection or transplant graft dysfunction. The Heart Molecular Microscope Diagnostic System (MMDx-Heart) and the Kidney Molecular Microscope Diagnostic System (MMDx-Kidney) are also considered investigational for the same purposes.
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