Demonstrates the clinical applicability of Tutivia™ to improve patient outcomes
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.”
Sara Barrington, CEO of Verici Dx, spoke to the In Vivo podcast. During the discussion, Sara outlines the current challenges facing patients post-transplant, how Verici Dx addresses these challenges, and where the overall transplant market is headed, considering the rise of home dialysis and the potential future for xenotransplants.
Verici Dx, a developer of advanced clinical diagnostics for organ transplant, announces that it has attained the ISO 27001 certification for its Information Security Management System (“ISMS”).
ISO 27001 is an international standard specifying requirements for an ISMS, and conformity with the standard means that Verici Dx’s system meets world-wide best practice with regards to managing risks related to the security of data owned or handled by the Company.
This certification underlines Verici Dx’s commitment to implementing comprehensive security measures, ensuring the protection of sensitive data and information, and reinforces the Company’s position as a trusted partner in industry and within patient care. With this certification, Verici Dx is well-equipped to continue delivering innovative diagnostic solutions while ensuring the highest level of protection for all sensitive information.
Dave Schultenover, VP Quality and Regulatory Affairs at Verici Dx, said: “We are pleased to have achieved the ISO 27001 certification, which underscores our unwavering commitment to maintaining the utmost security and confidentiality of data within our operations.”
Patti Connolly, Chief Operating Officer at Verici Dx, added: “Achieving this international standard is testament to the quality of the Verici Dx team, and the robustness of our systems and processes that maintain the highest level of data protection for patients, clients, partners, and stakeholders.”
Verici Dx attended and exhibited at the American Society of Nephrology’s annual conference, ASN Kidney Week, from 2-5 November 2023 in Philadelphia, PA. We were delighted to present a poster on the successful international clinical validation study for Clarava™, our pre-transplant blood-based prognostic test for the risk of early acute kidney transplant rejection.
The poster, titled “Multi-Center International Study to Validate a Pre-Transplant Blood-Based Next-Generation Sequencing (NGS) Signature Predicting Risk of Acute Rejection After Kidney Transplant”, described the design and positive results of Clarava’s™ successful validation study.
Clarava™ is the only pre-transplant test of its kind currently available that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including increasing or decreasing adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardised and typically based on the recipient’s race, age, previous transplant history and whether they have antibodies against common donor antigens. As previously reported, the Clarava™ personalised risk assessment is especially important for the expanding Deceased Donor transplant population.
Sara Barrington, CEO of Verici Dx, said: “ASN Kidney Week is an important platform for Verici Dx to raise awareness of its products including Clarava™, being the largest international gathering attended by kidney health professionals and featuring the latest advances in treatment, research and cutting edge technology in the field of nephrology.”
Agreement grants rights to further develop an assay for pre-transplant prognostic testing.
Cardiff, U.K. (November 15, 2023) – Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, today announced that it has signed an exclusive global licensing agreement with Thermo Fisher Scientific, the world leader in serving science, to further develop an assay for pre-transplant prognostic testing for risk of early kidney rejection.
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International clinical validation study data to be presented at the largest global gathering of kidney health professionals
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it will present a poster on the successful international clinical validation study for Clarava™, the Company’s pre-transplant blood-based prognostic test for the risk of early acute kidney transplant rejection, at the American Society of Nephrology’s annual conference, ASN Kidney Week, being held from 2-5 November 2023 in Philadelphia, PA.
The poster, titled “Multi-Center International Study to Validate a Pre-Transplant Blood-Based Next-Generation Sequencing (NGS) Signature Predicting Risk of Acute Rejection After Kidney Transplant”, will be presented from 10am-12pm on 2 November, in the Exhibit Hall at location TH-PO115.
The poster will describe the design and positive results of Clarava’s™ successful validation study, as previously announced, and is expected to help establish the product within the international nephrology community ahead of commercial launch.
Clarava™ is the only pre-transplant test of its kind currently available that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including increasing or decreasing adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardised and typically based on the recipient’s race, age, previous transplant history and whether they have antibodies against common donor antigens. As previously reported, the Clarava™ personalised risk assessment is especially important for the expanding Deceased Donor transplant population.
Sara Barrington, CEO of Verici Dx, said: “ASN Kidney Week is an important platform for Verici Dx to raise awareness of its products including Clarava™, being the largest international gathering attended by kidney health professionals and featuring the latest advances in treatment, research and cutting edge technology in the field of nephrology.”