Positive results for Clarava from validation study

Verici Dx plc

("Verici Dx" or the "Company") 

Positive results for Clarava™ from blinded multi-centre clinical validation study

Data validates Clarava's ability to identify patients likely to experience future kidney transplant rejection

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces the successful outcomes from its blinded, international, multi-centre validation study for Clarava™, the Company's pre-transplant blood-based prognostic test for the risk of early acute kidney transplant rejection.

Utilising a diverse validation population from 14 international transplant sites, the initial results of the validation study amongst the US kidney transplant patients followed up to date show that the Clarava™ diagnostic, which uses next-generation RNA sequencing, is an effective tool to identify patients likely to experience a future transplant rejection event prior to their surgery.

Clarava™ represents a novel pre-transplant approach to characterising a patient's immune-profile using their RNA signature. This is expected to have wide-ranging implications regarding treatment plans for each patient ahead of transplant, post-operatively and in terms of monitoring patient response. The Directors believe that the available data on Clarava™ positions it as a viable and compelling product for a broader patient population and commercialisation, as it has no directly competing products. These initial results from the Clarava™ validation study therefore mark a further, important step toward clinical acceptance and commercialisation of the test.

To generate broad clinical acceptance within the diverse international transplant community, Verici Dx is extending enrolment in its ongoing clinical validation study for an additional six-month period, using its existing network of 14 international transplant centres across Europe as well as the US. The expansion of the Clarava™ validation cohort is designed to enrich the utility data for the assay and support a statistically robust and clinically meaningful case for its adoption in due course. 

Sara Barrington, CEO, Verici Dx, said: "This new validating data demonstrates that Clarava™ can have a significant impact for transplant clinicians understanding of which patients could experience early acute rejection, pre-surgery. As a result, clinicians can make better decisions in advance that can help drive better outcomes post-transplant."

The extension of the validation study has no material impact on the Company's cash resources and runway, as the Clarava™ validation work is leveraging the ongoing, budgeted clinical validation study for Verici Dx's third product, Protega™, as each patient's sample can be used for multiple tests. Further updates on the Company's progress will be provided shortly in its interim results announcement, which is due to be released on 7 September 2022.

The information contained within this announcement is deemed by the Company to constitute inside information
as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR").
With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain. The Directors named below take responsibility for the release of this information.

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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, including through 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.