GraftAssureDx is intended to quantify relative (%) and absolute (cp/mL) levels of donor-derived cell-free DNA (dd-cfDNA) in plasma following kidney transplantation to aid in the assessment of the probability of allograft rejection at the time of testing in conjunction with standard clinical assessments.
GraftAssureDx has not been evaluated by the United States Food and Drug Administration and the safety and efficacy of GraftAssureDx has not been established. Currently, GraftAssureDx safety and efficacy is being evaluated in a clinical trial.
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©2025 Insight Molecular Diagnostics Inc. All rights reserved. iMDx, GraftAssureCore, GraftAssureIQ, GraftAssureDx, DetermaIO, DetermaCNI, and OncoTIME are trademarks of Insight Molecular Diagnostics Inc. All other trademarks are the property of their respective owners. For the intended uses of all products, please refer to www.imdxinc.com.
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1. Oellerich M, Shipkova M, Asendorf T, et al. (2019) Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant 19(11):3087. 2. Akifova A, Budde K, Choi M, et al. (2023). Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney International Reports doi:10.1016/j.ekir.2023.07.011. 3. Oellerich M, Sherwood K, Keown P, et al. (2021). Liquid biopsies: donor-derived cell-free DNA for the detection of kidney allograft injury. Nat Rev Nephrol 17(9):591. 4. Altug Y, Liang N, Ram R, et al. (2019). Analytical Validation of a Single-nucleotide Polymorphism-based Donor-derived Cell-free DNA Assay for Detecting Rejection in Kidney Transplant Patients. Transplantation 103(12):2657. 5. Grskovic M, Hiller DJ, Eubank LA, et al. (2016) Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn 18(6):890. 6. Beck J, Bierau S, Balzer S, et al. (2013) Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin Chem 59(12):1732. 7. Schutz E, Asendorf T, Beck J, et al. (2020) Time-dependent apparent increase in dd-cfDNA percentage in clinically stable patients between one and five years following kidney transplantation. Clin Chem 66(10):1290. 8. Osmanodja B, Akifova A, Budde K, et al. (2021). Absolute or Relative Quantification of Donor-derived Cell-free DNA in Kidney Transplant Recipients: Case Series. Transplant Direct 7(11):e778.
© 2024 Oncocyte Corporation. All Rights Reserved. The VitaGraft Kidney Test has been developed and its performance characteristics determined by Oncocyte. The VitaGraft Kidney Test has not been cleared or approved by the US Food and Drug Administration (FDA). Oncocyte’s laboratory oering the VitaGraft Kidney Test is CAP-accredited and CLIA-certified.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
iMDx Terms and Conditions of Sale shall govern the sale and purchase of the products quoted herein. Please see Terms and Conditions for additional details.
