Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that the data from the Company’s successful pivotal international validation study for Tutivia™ has been peer reviewed and published in The American Journal of Transplantation, the official journal of both the American Society of Transplantation and the American Society of Transplant Surgeons with a combined membership of approximately six thousand transplant professionals.
The publication, entitled ‘Prospective observational study to validate a Next Generation Sequencing blood RNA signature to predict early kidney transplant rejection’ by Bestard, O. et al. is available in The American Journal of Transplantation, Prospective observational study to validate a next-generation sequencing blood RNA signature to predict early kidney transplant rejection - ScienceDirect.
Tutivia™ is the Company’s post-transplant blood test that calculates the risk of all forms of acute rejection, including borderline, T cell-mediated, and antibody-mediated rejections. The test was commercially launched in January 2023 to support clinical care for the estimated c.100,000 global patients who undergo kidney transplant procedures annually.
Publication in a leading scientific journal is a crucial step in the commercialisation of a new product as the peer-review process supports the verification of the reliability and credibility of the research, building trust and confidence within the scientific community.
Publication is also a key element in the application by Verici Dx for Tutivia™ to obtain a local coverage determination
(“LCD”) for Medicare reimbursement, opening the test up for Medicare patients and increasing the likelihood of the
test being adopted by centres.
The data from the prospective, blinded study showed that Tutivia™, a next-generation RNA sequencing assay,
demonstrates strong performance in the assessment of risk of acute rejection following a kidney transplant. Tutivia™
delivers a significant improvement in biomarker offerings, particularly early post-transplant when patient management can be complex and other biomarkers are contraindicated or less informative. Patients with a high-risk Tutivia™ score are nearly six times as likely to have acute rejection over those with low-risk results. These findings confirm Tutivia™’s role in helping improve patient outcomes with significant implications for clinical care, providing relevant information for immunosuppression management and supporting clinical decision making with regard to kidney biopsy.
The strong results were particularly noteworthy given that the study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup and examined performance in both the for-cause and surveillance settings. The study was purposefully designed this way to capture the clinical reality across 13 international transplant centres in five countries. As a result, the data reflects the wide clinical applicability of Tutivia™ for comprehensive commercial adoption in a real-world setting.
Dr. Lorenzo Gallon, Chair of Scientific Advisory Board of Verici Dx, commented: “I am delighted that the data from our pivotal validation study for Tutivia™ has been published in such a high-impact and prestigious journal as The American Journal of Transplantation.”
Dr Michael Donovan, Chief Medical Officer of Verici Dx, added: “This publication further validates the benefits of the test for kidney transplant patients and their clinicians, and demonstrates the comprehensive design of the study to reflect the full clinical continuum.”
Patti Connolly, Chief Operating Officer, concluded: “We are already seeing growing clinical interest, and as this publication is key in the application for LCD coverage, we anticipate an accelerated adoption of Tutivia™ within the medical community, marking a significant step forward in enhancing diagnostic accuracy and post-transplant patient care.”