LAB.00038 Cell-free DNA Testing to Aid in the Monitoring of Kidney Transplants for Rejection Form

This document addresses the use of cell-free DNA (cfDNA) as a method of detecting kidney transplant recipients at risk for transplant rejection. cfDNA-based tests for detection of kidney transplant rejection may use blood or urine samples and include, but may not be limited to, QiSant^™ (NephroSant, Inc., Brisbane, CA), AlloSure^® (CareDX, Inc., San Francisco, CA), Transplant Rejection Allograft Check (TRAC^®) (Viracor, Lee's Summit, MO) and Prospera^™ Organ Transplant Rejection Assessment Test (Natera, Inc., San Carlos, CA). This document does not address the use of organ biopsy or serum creatinine monitoring to detect kidney transplant rejection.

Note: Please see the following related document for additional information:

• CG-TRANS-02 Kidney Transplantation

Position Statement

Investigational and Not Medically Necessary:

Cell-free DNA testing is considered investigational and not medically necessary as a non-invasive method of determining the risk of rejection in kidney transplant recipients.