#TruGraf blood test

[hilaris1]

Analytical and Clinical Validation of a Novel Blood- Based Biomarker of Liver Transplant Rejection

Weems JC, Pierry D, Holman J, Kandpal M, Kurian SM, Meintjes P, Beswick N, and Levitsky J. "Analytical and Clinical Validation of a Novel Blood-Based Biomarker of Liver Transplant Rejection." J Transplant Technol Res 11 (2021): 180.

Abstract Background: We have discovered and validated a microarray-based test that analyzes blood gene expression profiles (GEP) as an indicator of immune status in liver transplant recipients with stable liver function. Methods: Analytical performance studies to characterize stability of RNA in blood during collection and shipment, analytical sensitivity (input RNA concentration), analytical specificity (interfering substances) and assay performance (clinical validity, and intra-assay, inter-assay, inter- laboratory reproducibility). Results: Total RNA extracted from whole blood specimens collected in PAXgene Blood RNA tubes was stable up to 3 days at room temperature (stable RNA yield). Under routine ambient shipping conditions, storage and shipping temperatures did not affect results. However, specimen shipments exposed to temperatures >400°C or to ambient temperatures for >3 days were unacceptable for processing. Analytical sensitivity studies demonstrated tolerance to variation in RNA input (50 to 400 ng per 3’ IVT (in vitro transcript] labeling reaction). Specificity studies using genomic Jurkat DNA spiked into 3 ’IVT reactions at 10-20% demonstrated negligible assay interference. The test was reproducible across operators, runs, reagent lots, and laboratories. External validation demonstrated that the TruGraf Liver blood test accurately classified patients in 84% of 155 samples. Conclusions: The previously published biomarker is the first non-invasive test to be demonstrated to have clinical utility in assessing immune status of LT recipients with stable liver function and shows promise as a reasonable and necessary tool supporting personalizing immunosuppressive therapy.

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