Genetic Test Evaluation

understanding how genetic tests impact patient management

AlloSure (CareDx)

December 7, 2017

The reference standard for diagnosis of renal allograft rejection is needle biopsy, but it is not typically used to monitor for rejection due to risk of complications, patient discomfort, and cost. Rejection results from injury to the allograft and cell death, which are correlated with elevated plasma levels of donor-derived cell-free DNA (dd-cfDNA). Current methods used to monitor for renal transplant rejection are indirect measures of renal function that are not specific to transplant rejection. Tests that measure dd-cfDNA may offer a noninvasive, more sensitive, and specific assessment of allograft rejection that is safer and can be performed at more frequent intervals than needle biopsy allows. This report reviews 1 such test, AlloSure.