Performance in blinded multi-centre trial establishes new industry standard in detection of acute kidney transplant rejection and paves way for commercial launch in United States in 2022
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the successful outcomes from its blinded, international, multi-centre validation study for Tuteva™.
Tuteva™ is the Company’s post-transplant blood test focused on acute rejection, including sub-clinical rejection. The results of the validation study show that the test, a next-generation RNA sequencing assay, is demonstrating strong performance in the detection of acute rejection, following a kidney transplant.
The finalised data, to be presented at the American Transplant Congress in June 2022, demonstrates a significantly higher Positive Predictive Value (“PPV”) for Tuteva™ than currently available kidney transplant blood tests, without enhancement from clinical features, in a broad validation population. This successfully addresses the unmet need for actionable, novel (immune-pathway) biomarker data in this field which should assist clinicians in improving patient outcomes. These clinically important results position Tuteva™ for a 2022 commercial launch to support the estimated c. 100,000 global patients who undergo kidney transplant procedures annually.
The strong results are particularly noteworthy given that the validation study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup. The Tuteva™ study was purposefully designed this way to capture the clinical reality of all types of rejection, including sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection across 14 international transplant centres. The results reflect the wide clinical applicability of the test for comprehensive commercial adoption in a real-world setting.
Dr. Roslyn Mannon, Professor of Internal Medicine, the Vice Chair of Research Mentoring and Academic Development in Internal Medicine, and Associate Chief of Research, Division of Nephrology at University of Nebraska, said: “Clinicians value study results that are reflective of what they see in their patient base in their clinics. Positive validation of Tuteva™ using a study design for that purpose gives clinicians confidence that this test can support critical clinician decision-making in the complex management of kidney transplant patients. With this positive predictive performance, Tuteva™ can now warn doctors in advance if kidney rejection is starting or likely to occur, allowing timely intervention to improve graft function and long-term survival.”
Dr. Lorenzo Gallon, Medical Director of the Translational Medicine Programme, the Director of International Relations and the Director of the Renal Transplant Fellowship at Northwestern University, Chair, Science Advisory Board and Non-Executive Director for Verici Dx, said: “In the kidney transplant environment where the chance of a rejection event is high, the clinician needs early, accurate and actionable information to make key treatment decisions. Prior to Tuteva clinicians did not have the tools capable of positively predicting rejections with high performance.”
Sara Barrington, CEO, Verici Dx, said: “It is an honour to announce the validation results of the pioneering work of the late Dr. Barbara Murphy. Spun out of Renalytix (NASDAQ RNLX, LSE RENX), the underlying technology is proving to be clinically groundbreaking, and we remain focused upon making this generally available to transplant patients. It is rewarding to see, in a blinded study, the validation of powerful tools that support improved clinical diagnosis of rejection allowing for more effective, earlier intervention. We look forward to presenting the full data at the American Transplant Congress in June.”
In addition to this positive read-out, Verici expects to announce multi-centre clinical validation results for Clarava™, the pre-transplant prognostic test within the coming weeks.
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
Sara Barrington, CEO
Julian Baines, Chairman
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Verici Dx is a developer of a complementary suite of leading-edge tests forming a kidney transplant platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure from pre-transplant to late stage. The Company also has a mission to accelerate the pace of innovation by research using the fully characterised data from the underlying technology and collaboration with medical device, biopharmaceutical and data science partners.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.