Transplant Genomics, Inc.
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).
* To characterize time-updated viral detection patterns (e.g., transient vs sustained CMV or BK signals) identified by T-ID prior to development of CMV disease or BKVAN. * To evaluate the clinical utility of T-ID monitoring, defined by the frequency and type of clinical management actions taken following test results. * To estimate the diagnostic performance of T-ID for clinically meaningful viral infection compared with standard-of-care (PCR) testing and clinical adjudication. * To quantify lead time between T-ID detection of viral cfDNA and standard-of-care confirmation or initiation of ther…
Inclusion Criteria: * Participants must meet all the following criteria: * Written informed consent and HIPAA authorization obtained prior to any study-related data collection. * Age ≥18 years at the time of enrollment. * Recipient of a kidney transplant, including: * Primary or repeat kidney transplantation * Living-donor or deceased-donor transplantation * At 1 month post-kidney transplant at the time of enrollment. * Receiving maintenance immunosuppressive therapy per institutional standard of care. * Selected by the treating provider to undergo TRAC testing as part of usu…
Blood collection