25% of patients with stable renal function are experiencing silent rejection that could lead to worse outcomes1
Subclinical Acute Rejection (subAR), which is “silent” (i.e., occurs in advance of any signs of graft damage such as a rise in creatinine or cell-free donor derived DNA) and therefore undetected unless surveillance biopsies are performed, affects ~35% of kidney transplant recipients in the first two (2) years post-transplant and has significant implications for long-term graft survival.
TruGraf® is a clinically validated, blood-based gene expression assay with negative predictive values of 89 − 91%, meaning that patients who would have displayed normal histology following surveillance biopsy have a ~ 90% chance of receiving a negative TruGraf® test – making it a highly effective “rule out” test for routine surveillance of patients with stable renal function.
A negative TruGraf® result, which is reported as “TX” (for Transplant eXcellence), has been demonstrated to be correct 94% of the time in studies involving testing of blood samples from patients with stable renal function who had simultaneous surveillance biopsies confirming normal histology. Transplant programs that employ a serial testing strategy using TruGraf® in stable patients have the potential to dramatically reduce the number of surveillance biopsies performed.
A serial testing strategy relying on TruGraf® provides an attractive alternative for programs that do not routinely perform protocol biopsies, enabling them to stratify their stable patient population into those likely to be adequately immunosuppressed or not, without waiting for onset of clinical symptoms to guide therapy.
TruGraf® is the first non-invasive blood test clinicians can use to help assess whether their patients are adequately immunosuppressed, prior to a rise in their serum creatinine (at which point damage to the kidney has already occurred), without having to perform a risky invasive protocol biopsy.
TruGraf®, the first and only non-invasive tool validated and covered by CMS as an alternative to surveillance biopsies to rule out silent subclinical rejection in patients with stable graft function.
Key benefits of serial testing with TruGraf® include:
- Patients benefit by avoiding painful, risky, invasive procedures that are negative 75% of the time
- Patients and their caregivers benefit from the knowledge that they don’t harbor silent subclinical rejection without having to undergo an invasive procedure
- Transplant clinicians benefit by stratifying patients into those who may benefit from surveillance biopsy and those who likely won’t, allowing them to eliminate a large percentage of surveillance biopsies that would likely have been negative if performed
- Friedwald JJ, et al., Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplant, American Journal of Transplantation, July 2019, 98-109.
- Primary research study by CLINICevAL Solutions, LLC, 2019
- First MR, Pierry D, McNulty M, Kurian SM, Rose S, Whisenant T, et al. Analytical performance validation of a molecular diagnostic signature in kidney transplant recipients. J Transplant Technol Res 2017;7:176. https://doi.org/10.4172/2161-0991.1000176.
- First MR, Peddi VR, Mannon R, et al. Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice. Transplantation Proceedings, 2019, 51, 729-733. https://doi.org/10.1016/j.transpro¬ceed.2018.10.024.
- Marsh C, Kurian SM, Rice J, et al. Application of TruGraf® v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients with Stable Renal Function. Transplantation Proceedings. April 2019; Epub 26, January 2019.
- Local Coverage Determination MolDX: TruGraf Blood Gene Expression Test (DL38039). Effective Date of Reimbursement: 25, November, 2019 from cms.gov.