Verici Dx Regulatory News (VRCI)

Verici Dx plc

("Verici Dx" or the "Company") 

Clarava™ and Tuteva™ complete testing requirements for completion of clinical validation study

Primary data analysis of two lead products on track for Q1 2022 read-out

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that its two leading products have completed the testing requirements of the multi-centre validation study, in line with the Company's expectations to have done so by the end of 2021. Reaching the clinical endpoints of the study means that, for both products, sufficient numbers of participants have completed the required follow-up to outcomes assessment, including biopsy findings, which are required for the full data analysis and clinical study report to be conducted in Q1 2022, as per the Company's targets.

The Company's two leading products aim to understand how a patient will and is responding to kidney transplantation:

· Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection; and

· Tuteva™ is a post-transplant test focused upon acute cellular rejection, including sub-clinical rejection as correlates to histopathology findings.

Verici Dx has partnered with fourteen leading US, Australian and EU centres in its collaborative, multi-centre clinical validation study. As previously announced, patient enrolment for both Clarava and Tuteva performance evaluation was completed ahead of schedule in August 2021, and we are grateful to all of the participating sites and their clinical teams for achieving this. The extent of commitment shown by these leading centres is testament to the recognition of the robust, scientific approach being taken by Verici Dx to its data gathering and analysis, and to the shared desire to make much-needed and potentially very significant gains in transplant patient outcomes.

As announced on 11 January 2021, Verici Dx in-licensed additional intellectual property (IP) relating to gene expression in a blood-based test (liquid biopsy) to predict the risk of fibrosis or chronic kidney graft damage. This is being commercialised under the product name, ProtegaTM and extends the Verici Dx portfolio across the full transplant patient journey by focusing on the prognosis of longer-term graft failure. Protega™ augments the Company's portfolio into an end-to-end transplant testing suite, from pre-transplant and short-term post-transplant to also include later-stage risk assessment. 

The current fourteen clinical trial sites participating in the validation study for Clarava™ and Tuteva™ will continue the enrolment of patients for an extended period for the validation study of Protega and is expected to reach target by the end of Q3 next year. The potential to inform earlier clinical interventions with treatments such as anti-fibrotic therapies ahead of irreversible organ damage is another key step to improving transplant outcomes. 

Patti Connolly, Executive VP, Product Development of Verici Dx, said: "We are pleased that both Clarava™ and Tuteva™ have not only exceeded the enrolment objectives for the clinical validation study in terms of numbers of sites and participants, but also completed testing in line with our expectations. This is another step towards the commercialisation of our two lead products, and we look forward to the data analysis and reporting of key findings in Q1 2022, with additional analyses to follow.

"I'd like to extend Verici Dx's gratitude to all of the kidney transplant patients participating in our studies as well as thanks to our fourteen collaborating centres across the US, Australia and EU who have partnered with us to bring these innovative in vitro diagnostics closer to the clinic. We look forward to sharing the validation reporting in 2022 as we approach commercial readiness for our two lead products and continue with validation for our third product."

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About Verici Dx plc www.vericidx.com

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.