Verici Dx Regulatory News (VRCI)

Verici Dx plc

("Verici Dx" or the "Company")

Clinical study validating PTRA test published

Verici Dx Plc, (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces 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."

Verici Dx

Verici Dx plc (AIM: VRCI) is a precision diagnostics company transforming care for transplant patients. The company combines multiomic analysis with proprietary artificial intelligence to deliver predictive, actionable, data-driven intelligence that reflects the complexity and heterogeneity of transplant patients, enabling clinicians to optimise therapy, guide biopsy decisions, and stratify risk with greater confidence.

Operating at the intersection of laboratory and data science, Verici Dx develops complex models that answer the clinical questions that matter most with unrivaled 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 UK 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.