C L Marsh1, S M Kurian2, J C Rice3, T C Whisenant4, J David5, S Rose5, C Schieve5, D Lee5, J Case2, B Barrick2, V R Peddi6, R B Mannon7, R Knight8, D Maluf9, D Mandelbrot10, A Patel11, J J Friedewald12, M M Abecassis12, M R First13. 1. Scripps Center for Organ Transplantation, La Jolla, California, United States; Scripps Clinic Bio-Repository and Transplantation Research, La Jolla, California, United States. Electronic address: marsh.christopher@scrippshealth.org. 2. Scripps Clinic Bio-Repository and Transplantation Research, La Jolla, California, United States. 3. Scripps Center for Organ Transplantation, La Jolla, California, United States. 4. University of California, San Diego, School of Medicine, Center for Computational Biology and Bioinformatics, La Jolla, California, United States. 5. Transplant Genomics Inc, Mansfield, Massachusetts, United States. 6. California Pacific Medical Center, San Francisco, California, United States. 7. University of Alabama School of Medicine, Birmingham, Alabama, United States. 8. Houston Methodist Hospital, Houston, Texas, United States. 9. University of Virginia, Charlottesville, Virginia, United States. 10. University of Wisconsin, Madison, Wisconsin, United States. 11. Henry Ford Hospital, Detroit, Michigan, United States. 12. Comprehensive Transplant Center, Northwestern University, Chicago, Illionis, United States. 13. Transplant Genomics Inc, Mansfield, Massachusetts, United States; Comprehensive Transplant Center, Northwestern University, Chicago, Illionis, United States.
Abstract
TruGraf v1 is a laboratory-developed DNA microarray-based gene expression blood test to enable proactive noninvasive serial assessment of kidney transplant recipients with stable renal function. It has been previously validated in patients identified as Transplant eXcellence (TX: stable serum creatinine, normal biopsy results, indicative of immune quiescence), and not-TX (renal dysfunction and/or rejection on biopsy results). TruGraf v1 is intended for use in subjects with stable renal function to measure the immune status as an alternative to invasive, expensive, and risky surveillance biopsies. MATERIALS AND METHODS: In this study, simultaneous blood tests and clinical assessments were performed in 192 patients from 7 transplant centers to evaluate TruGraf v1. The molecular testing laboratory was blinded to renal function and biopsy results. RESULTS: Overall, TruGraf v1 accuracy (concordance between TruGraf v1 result and clinical and/or histologic assessment) was 74% (142/192), and a result of TX was accurate in 116 of 125 (93%). The negative predictive value for TruGraf v1 was 90%, with a sensitivity 74% and specificity of 73%. Results did not significantly differ in patients with a biopsy-confirmed diagnosis vs those without a biopsy. CONCLUSIONS: TruGraf v1 can potentially support a clinical decision enabling unnecessary surveillance biopsies with high confidence, making it an invaluable addition to the transplant physician's tool kit for managing patients. TruGraf v1 testing can potentially avoid painful and risky invasive biopsies, reduce health care costs, and enable frequent assessment of patients with stable renal function to confirm the presence of immune quiescence in the peripheral blood.
TruGraf v1 is a laboratory-developed DNA microarray-based gene expression blood test to enable proactive noninvasive serial assessment of kidney transplant recipients with stable renal function. It has been previously validated in patients identified as Transplant eXcellence (TX: stable serum creatinine, normal biopsy results, indicative of immune quiescence), and not-TX (renal dysfunction and/or rejection on biopsy results). TruGraf v1 is intended for use in subjects with stable renal function to measure the immune status as an alternative to invasive, expensive, and risky surveillance biopsies. MATERIALS AND METHODS: In this study, simultaneous blood tests and clinical assessments were performed in 192 patients from 7 transplant centers to evaluate TruGraf v1. The molecular testing laboratory was blinded to renal function and biopsy results. RESULTS: Overall, TruGraf v1 accuracy (concordance between TruGraf v1 result and clinical and/or histologic assessment) was 74% (142/192), and a result of TX was accurate in 116 of 125 (93%). The negative predictive value for TruGraf v1 was 90%, with a sensitivity 74% and specificity of 73%. Results did not significantly differ in patients with a biopsy-confirmed diagnosis vs those without a biopsy. CONCLUSIONS: TruGraf v1 can potentially support a clinical decision enabling unnecessary surveillance biopsies with high confidence, making it an invaluable addition to the transplant physician's tool kit for managing patients. TruGraf v1 testing can potentially avoid painful and risky invasive biopsies, reduce health care costs, and enable frequent assessment of patients with stable renal function to confirm the presence of immune quiescence in the peripheral blood.
Authors: Sookhyeon Park; Kexin Guo; Raymond L Heilman; Emilio D Poggio; David J Taber; Christopher L Marsh; Sunil M Kurian; Steve Kleiboeker; Juston Weems; John Holman; Lihui Zhao; Rohita Sinha; Susan Brietigam; Christabel Rebello; Michael M Abecassis; John J Friedewald Journal: Clin J Am Soc Nephrol Date: 2021-10 Impact factor: 10.614