OBJECTIVES: Advances in molecular diagnostics for the detection of disease can provide opportunities for healthcare providers to intervene earlier and subsequently, improve outcomes. Payers are increasingly focused on assessing the cost and overall value of such tools. The kSORT assay is a non-invasive test that can be used as a screening tool to detect subclinical rejection (SCR) among kidney transplant patients. The current standard of care may consist of routine screening for clinical acute rejection (AR) or the use of invasive surveillance biopsies to detect SCR through histologic diagnosis. Preliminary data show that the k-SORT assay performs as well as and potentially superior to biopsies for the detection of SCR and prediction of AR. The objective of this analysis is to evaluate the potential budget impact of the kSORT assay from a commercial payer perspective using a set of conservative assumptions. METHODS: A 2-year Markov model incorporating SCR, AR, and graft failure was developed to evaluate the budget impact from a U.S. commercial payer perspective of the k-SORT assay among patients with incident kidney transplants. Probabilities for progression were obtained by calibrating the values to correspond with reported prevalence rates of SCR and incidence rates of AR from published registry data.  Costs were obtained through the peer-reviewed literature and sensitivity analyses were performed. RESULTS: Across a set of conservative assumptions, use of the kSORT assay may have a minimal budget impact (<$0.05) PMPM across most scenarios. Key value drivers include the frequency of monitoring, costs of the assay, and concurrent use of protocol biopsies with the assay. CONCLUSIONS: The use of k-SORT to detect SCR is likely to produce a minimal budget impact for commercial payers. Additional studies demonstrating the clinical performance of the assay compared to biopsies can help to provide further insight into the clinical and economic benefits.