Verici Dx Plc (LON:VRCI), a developer of advanced clinical diagnostics for organ transplant, has announced the publication of a peer-reviewed clinical validation study of its Pre-Transplant Rejection Assessment (PTRA) test. The study, titled ‘A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection’ has been published in Kidney360(1). The PTRA test is commercially marketed by Thermo Fisher Scientific(2).
The study showed that the PTRA test outperformed conventional risk assessment tools in the ability to predict Early Acute Rejection (EAR) in the first two months following transplant, enabling clinicians to identify patients who may benefit from safe minimisation of therapy while effectively managing risk of early rejection. Currently, kidney transplant recipients receive standardised immunosuppressive regimens, with more aggressive therapy reserved for patients perceived as high-risk. However, these conventional risk features have limited predictive value, which can lead to unnecessary over-suppression and risks related to toxicity, infections and malignancy.
(1) Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Nephrology
(2) The PTRA test is a laboratory developed test that is used for clinical purposes by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. Food and Drug Administration (“FDA”) or CE marked in the EU as an in vitro diagnostic test.
Beatrice Concepcion, Medical Director, Kidney and Pancreas Transplant, University of Chicago Medicine, said: “The data from this study demonstrates that PTRA provides clinically meaningful, recipient-specific risk stratification. This creates the opportunity to identify low-risk patients in whom we may safely reduce immunosuppressive therapy, addressing a long-standing unmet need in transplant medicine. By aiding clinicians in risk assessing recipients, PTRA offers an advancement in support for how we manage immunosuppression.”
Patti Connolly, Chief Operating Officer of Verici Dx, said: “We are delighted that the publication of this study further validates PTRA for predicting EAR in kidney transplant recipients. The test enables a more personalised approach to immunosuppression management during the critical early post-transplant period and supports clinicians in the identification of patients at low immunologic risk of EAR, which may allow the recipient to be considered for less aggressive immunosuppressive regimens.”
