- Test outperformed conventional risk metrics in predicting early acute rejection in the first two months following deceased donor kidney transplant
- Enables clinicians in identifying patients who may benefit from safe minimization of therapy while effectively managing risk of early rejection
- Demonstrated to operate mostly independently of donor characteristics, reinforcing the central role of the recipient’s immune phenotype in guiding early transplant care decisions
FRANKLIN, Tenn.--(BUSINESS WIRE)--Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, today announced the publication of a peer-reviewed clinical validation study of the Pre-Transplant Rejection Assessment (PTRA) test that stratifies patients undergoing deceased donor kidney transplantation as to their risk of acute rejection in the first two months post-transplant. The study, entitled “A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection” was published in Kidney360. The PTRA test is commercially marketed by Thermo Fisher Scientific.*
“The recipient-specific test enables a more personalized approach to immunosuppression management during the critical early post-transplant period,” said Patti Connolly, Chief Operating Officer of Verici Dx. “PTRA supports clinicians in identification of patients at low immunologic risk of Early Acute Rejection (EAR) which may allow the recipient to be considered for less aggressive immunosuppressive regimens. This risk stratification addresses a critical concern in transplantation, as over-immunosuppression can increase the risk of infection, drug toxicity, and malignancy.”
The test consists of an RNA signature comprised of 29 genes involved in oxidative stress, endothelial injury, metabolic regulation, as well as immune pathways associated with T cell– and antibody-mediated mechanisms of rejection. The test was observed in the clinical validation study to operate mostly independently of donor characteristics, focusing instead on an intrinsic, recipient-specific rejection phenotype, and demonstrates superior performance compared with standard risk features.
PTRA outperformed conventional risk assessment tools, including panel reactive antibodies (PRA) in the ability to predict EAR in the first two months following transplant.
Currently, kidney transplant recipients receive standardized immunosuppressive regimens, with more aggressive therapy often reserved for patients perceived as high-risk, typically based on broad criteria such as high PRA levels. However, these conventional risk features have limited predictive value, which can lead to unnecessary over-suppression and risks related to toxicity, infections and malignancy.
Despite decades of progress in transplant medicine, clinicians still rely largely on broad, population-based risk markers that lack the precision needed to guide more individualized care. As a result, immunosuppressive strategies have remained largely one-size-fits-all for more than a decade.
“The data from this study demonstrate that PTRA provides clinically meaningful, recipient-specific risk stratification,” said Beatrice Concepcion, MD, Medical Director, Kidney and Pancreas Transplant, University of Chicago Medicine. “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."
About Verici Dx
Verici Dx plc (AIM: VRCI) is a precision diagnostics company transforming care for transplant patients. The company combines multiomic analyses with proprietary artificial intelligence to deliver predictive, actionable, data-driven intelligence that reflects the complexity and heterogeneity of transplant patients, enabling clinicians to optimize therapy, guide biopsy decisions, and stratify risk with greater confidence. Operating at the intersection of laboratory and data science, Verici Dx develops complex models to answer the clinical questions that matter most with clarity and precision. All tests are built to rigorous scientific standards, validated across inclusive and real-world patient populations to ensure clinical relevance and reliability. Verici Dx’s lead product, Tutivia™, is a post-kidney transplant test focused on early detection of acute rejection. The company is headquartered in Cardiff for the UK, and in Franklin, Tennessee for the U.S. For more information, please visit https://vericidx.com/ and follow us on LinkedIn.
*The Pre-Transplant Rejection Assessment (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.
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