Strategic decision to expand study without impacting commercial pathway
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that whilst it has met the study size criteria, a decision has been taken to expand its clinical validation study for its lead products, ClaravaTM and TutevaTM , by approximately four to six weeks to allow the inclusion of more verified data from European sites, and therein increase the robustness of the study. The Board does not expect this to have any impact on the Company’s recently outlined commercialisation pathway and the Company remains on track to present results to the clinical community at ATC (American Transplant Congress) in early June, as planned. Verici Dx believes it will be able to meet its launch plans within this year, as expected.
All the data from the validation study currently remains “blinded” and therefore the Company has not yet had access to the performance analysis of the study.
The reason for this decision is due to a delay in compliance visits from the Company’s European study sites. The inclusion of their data is significant as it contributes to ensuring an evenly distributed study population across all participating sites. This is an important aspect to ensure the robustness of the study for commercial launch. Unlike the US sites, where compliance monitoring can be undertaken remotely, the sites in Italy, France, and Spain require onsite in-person monitoring, which has recently been hampered by restrictions due to COVID-19, hence the delay
in inclusion of their data.
Sara Barrington, Chief Executive Officer, Verici Dx, said: “Our timelines are such that we have the scope to make a positive strategic choice to increase the robustness of the study and ensure strong representation from our European partners, as we initially intended, without impacting our commercial timelines. Importantly the study data remain blinded, and this decision has been made in line with the original study design for geographic diversity, with the added benefit of increasing the total number of patients in the study. We remain on track to present to the clinical community at ATC in early June, as planned, with Verici Dx on course to deliver on the launch plans for our two lead products by the year-end of the year.”
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.