Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice

First, M. Roy; Peddi, V. Ram; Mannon, Roslyn B.; Knight, Richard J.; Marsh, Christopher L.; Kurian, Sunil M.; Rice, J. C.; Maluf, Daniel G.; Mandelbrot, Didier A.; Patel, Anita; David, J.; Schieve, C.; Lee, D.; Lewis, Peter J.; Friedewald, John; Abécassis, Michaël; Rose, Stan

doi:10.1016/j.transproceed.2018.10.024

Cited by 14 publications

(17 citation statements)

References 7 publications

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“…18 They found that TruGraf testing supported physician decisions 87% of the time, and 54% reported that results would have confirmed their decision that no intervention, such as biopsy or change in therapy, would be needed. 18 The key concept behind this test is that it can provide physicians with reassurance that the patients whose tests are reported back as TX, or "Transplant eXcellence," can continue to be monitored with serial testing as opposed to undergoing an invasive (SBx). The goal of the current study was to assess TruGraf testing in a real-world setting and to correlate the TruGraf™ test with the histology findings on a 6-month SBx, determine clinical utility of TruGraf results, and evaluate follow-up of patient outcomes for 1 year after the SBx.…”

Section: Accuracy (Concordance Between Trugraf Test Results and Histolmentioning

confidence: 98%

“…4 Clinical utility is generally defined as a test's ability to support a physician's treatment plan, its ability to impact decisions in changing a physician's treatment plan, and whether the physician deems the test reasonable or even necessary to provide optimal care. The clinical utility in this study was determined by investigator questionnaire previously described 18 and summarized in Table 3. The TruGraf test was performed on the day of the biopsy.…”

Section: Discussionmentioning

confidence: 99%

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Avoiding surveillance biopsy: Use of a noninvasive biomarker assay in a real‐life scenario

Ang

Schieve

Rose

et al. 2020

Clinical Transplantation

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Purpose TruGraf™ blood test measures a specific gene expression signature in peripheral blood mononuclear cells for noninvasive assessment of kidney transplant recipients (KTRs) with stable renal function, excluding subclinical acute rejection (subAR) with high degree of confidence. Study objective was to correlate TruGraf™ test with 6‐month surveillance biopsy (SBx). Methods Prospective, single‐center study of 116 consecutive KTRs with SBx performed at 6 months post‐transplant..TruGraf™ done at time of SBx; results compared with histology (Banff 2017) for concordance. Results Of 116 enrollees, 26 excluded, absent biopsy (n = 17), test quality control issues (n = 9), leaving 90 KTRs—66% deceased donor kidneys, 58% African American, and 59% male. TruGraf™ result negative in 67 subjects; 54 had normal biopsy, indicating SBx could have been avoided. Eight subjects had true positive result where biopsy justified. Unnecessary biopsy would have been performed in 15 subjects with false‐positive TruGraf™, and subAR missed in 13 subjects with false‐negative test. In overall population of 90 patients, SBx would have been avoided in 54 (60%). Conclusions Implementation of TruGraf™ testing in a “real‐world” cohort at the time of SBx identified a significant proportion of KTRs that could have avoided SBx.

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Section: Accuracy (Concordance Between Trugraf Test Results and Histolmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Avoiding surveillance biopsy: Use of a noninvasive biomarker assay in a real‐life scenario

Ang

Schieve

Rose

et al. 2020

Clinical Transplantation

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“…The lower PPV of this test for subAR limits the value of a single positive test. Clinical utility was assessed through both retrospective and prospective surveys of physician decision impact 20. A recent study has suggested the prognostic potential of this test by demonstrating a correlation with graft outcomes at 24 months following kidney transplantation 21.…”

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confidence: 99%

A Practical Guide to the Clinical Implementation of Biomarkers for Subclinical Rejection Following Kidney Transplantation

et al. 2020

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Noninvasive biomarkers are needed to monitor stable patients following kidney transplantation (KT), as subclinical rejection, currently detectable only with invasive surveillance biopsies, can lead to chronic rejection and graft loss. Several biomarkers have recently been developed to detect rejection in KT recipients, using different technologies as well as varying clinical monitoring strategies defined as “context of use (COU).” The various metrics utilized to evaluate the performance of each biomarker can also vary, depending on their intended COU. As the use of molecular biomarkers in transplantation represents a new era in patient management, it is important for clinicians to better understand the process by which the incremental value of each biomarkers is evaluated to determine its potential role in clinical practice. This process includes but is not limited to an assessment of clinical validity and utility, but to define these, the clinician must first appreciate the trajectory of a biomarker from bench to bedside as well as the regulatory and other requirements needed to navigate this course successfully. This overview summarizes this process, providing a framework that can be used by clinicians as a practical guide in general, and more specifically in the context of subclinical rejection following KT. In addition, we have reviewed available as well as promising biomarkers for this purpose in terms of the clinical need, COU, assessment of biomarker performance relevant to both the need and COU, assessment of biomarker benefits and risks relevant to the COU, and the evidentiary criteria of the biomarker relevant to the COU compared with the current standard of care. We also provide an insight into the path required to make biomarkers commercially available once they have been developed and validated so that they used by clinicians outside the research context in every day clinical practice.

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“…In 2019, First et al[ 32 ] expanded on these findings with TruGraf ® in their study both retrospectively and prospectively. In their retrospective arm, they found that in the evaluation of 192 patients at 7 transplant centers, in 87.5% of the cases, investigators’ clinical decisions were influenced by TruGraf ® test results.…”

Section: Novel Biomarker Classificationmentioning

confidence: 99%

“…In the prospective arm of 45 patients at 5 centers, TruGraf ® supported 87% of the clinical decisions with 93% of investigators stating they would use TruGraf ® in subsequent patient care. In these studies, TruGraf ® often led to the non-invasive diagnosis, affirming conservative approaches as well as obviating the need for biopsy[ 32 ].…”

Section: Novel Biomarker Classificationmentioning

confidence: 99%

Role of novel biomarkers in kidney transplantation

Swanson

Aziz

Garg

et al. 2020

WJT

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Clinical application of biomarkers is an integral component of transplant care. Clinicians and scientists alike are in search of better biomarkers than the current serologic (serum creatinine, donor-specific antibodies), urine-derived (urinalysis, urine protein), and histologic ones we now use. The science behind recent biomarker discovery spans across multiple molecular biologic disciplines, including transcriptomics, proteomics, and metabolomics. Innovative methodology and integration of basic and clinical approaches have allowed researchers to unearth molecular phenomena preceding clinical disease. Biomarkers can be classified in several ways. In this review, we have classified them via their origin and outcome: Primarily immunologic, i.e ., representative of immune regulation and dysfunction and non-immunologic, pertaining to delayed graft function, cardiovascular events/mortality, infection, malignancy, post-transplant diabetes, graft, and patient survival. Novel biomarker uses to guide the diagnosis and management of transplant-related outcomes is a promising area of research. However, the use of biomarkers to predict outcomes after kidney transplantation is not well studied. In this review, we summarize the recent studies illustrating biomarker use and transplant outcomes.

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Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice

Cited by 14 publications

References 7 publications

Avoiding surveillance biopsy: Use of a noninvasive biomarker assay in a real‐life scenario

Avoiding surveillance biopsy: Use of a noninvasive biomarker assay in a real‐life scenario

A Practical Guide to the Clinical Implementation of Biomarkers for Subclinical Rejection Following Kidney Transplantation

Role of novel biomarkers in kidney transplantation

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