Verici Dx remains on track for completion of study end points by the end of 2021 for lead products
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that patient enrolment for a multi-centre observational clinical validation study for the Company’s lead products has concluded ahead of management expectations. Early completion of enrolment supports that the Company remains on track to complete the validation study for these products by the end of 2021, in line with expectations set out in the Company’s admission document.
Verici Dx has partnered with eleven leading US and EU centres to date to run a global, non-randomised study for the clinical validation of Verici Dx’s lead products, ClaravaTM and TutevaTM.
The study uses next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of the lead Verici Dx signature tests.
Over the longer term, the study will also provide validation for the Company’s fibrosis test, called Protega™. Patient enrolment continues for validation of Protega and is expected to complete by Q3 2022. The end points of the validation study for this product are expected to be reached up to two years after the completion of enrolment, with data expected shortly thereafter around year-end 2024.
Sara Barrington, CEO of Verici Dx, said: “I am delighted to have reached this key milestone ahead of our original expectations. Since IPO our primary focus has been on the successful prosecution of these clinical trials, as the first key step in commercialising our innovative transplant products.
“We remain on track to have our two lead products fully tested by the end of the year and look forward to reporting the data in Q1 2022.”
Sara Barrington, CEO
Julian Baines, Chairman
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Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
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.