Laboratory Tests For Heart And Kidney Transplant Rejection

Clinical assessment and noninvasive imaging of chronic heart failure can be limited in accurately diagnosing patients with heart failure because symptoms and signs can poorly correlate with objective methods of assessing cardiac dysfunction. For management of heart failure, clinical signs and symptoms (eg, shortness of breath) are relatively crude markers of decompensation and occur late in the course of an exacerbation. Thus, circulating biomarkers have potential benefit in heart failure diagnosis and management. In transplant recipients, despite the progress in immunosuppressant therapy, the risk of rejection remains. Diagnosis of allograft rejection continues to rely on clinical monitoring and histologic confirmation by tissue biopsy. However, due to limitations of tissue biopsy, including a high degree of interobserver variability in the grading of results and its potential complications, less invasive alternatives have been investigated. Several laboratory-tested biomarkers of transplant rejection have been evaluated and are commercially available for use. The laboratory tests for heart transplant rejection currently evaluated in this policy include the Presage® ST2 Assay kit, which measures the soluble suppression of tumorigenicity-2 (sST2) protein biomarker; ; the Heartsbreath test, which measures breath markers of oxidative stress; the AlloSure, Prospera Heart and myTAIHEART tests for assessment of donor-derived cell-free DNA (dd-cfDNA); the AlloMap test, which uses gene expression profiling (GEP); and the HeartCare test, which combines AlloMap GEP testing with the AlloSure test. Also included in this policy are the AlloSure and Prospera dd-cfDNA tests for assessment of renal and lung transplant rejection.