Verici Dx Regulatory News (VRCI)

Verici Dx plc

("Verici Dx" or the "Company") 

Appointment of Senior Director of Clinical Trial Operations

Preparatory phase for validation trials complete

Site initiation of transplant centres on track for January 2021

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has appointed Angela Rose as Senior Director, Clinical Trial Operations with immediate effect.

Angela, a senior clinical trial project management professional with over 15 years of experience in managing medical device, diagnostics, biologic and drug global clinical trial operations for regulatory approval, will be responsible for overseeing Verici Dx's planned multi-centre observational clinical validation studies for its two flagship in vitro diagnostic assays, Clarava™ and Tuteva™. Clarava™ is a pre-transplant prognosis for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. These tests have the potential to define a personalised risk profile of kidney transplant patients over the course of their transplant journey and may also detect injury in advance of currently available clinical tests.

The preparatory phase for these validation studies has now been completed following the Company's successful IPO fundraise in November 2020, and Angela will be instrumental in overseeing the clinical trial operations to the conclusion of the studies.

Angela joins Verici Dx from regenerative medicine biotech company Humacyte Inc., where she was responsible for global operational oversight and delivery of their clinical development projects and clinical trials. Angela's extensive experience in clinical project management includes prior roles at biotech pharma company BioCryst Pharmaceuticals Inc., global contract research organisation Quintiles, biopharmaceutical firm Gilead Sciences, Inc., and infectious disease diagnostics company bioMérieux, Inc. Angela's educational training at Duke University specialised in clinical laboratory science and, together with her industry experience in trials, positions her to engage in validation of diagnostic testing with deep understanding of the field in a commercial context.

Commenting on Angela's appointment Sara Barrington, CEO of Verici Dx, said:

"We are delighted to have someone with Angela's experience in clinical trial project management on board to oversee our clinical validation studies focused on Clarava™ and Tuteva™. We are on track to commence enrolment in transplant centres in the new year for trials to be conducted in 2021. Successful conclusion will validate our key products at the forefront of kidney transplant diagnostics."

About the validation trials

The multi-centre observational clinical study will seek to validate the clinical performance of gene expression immune-phenotyping signatures and associated algorithms for the Company's in vitro diagnostic assays. The study will allow clinico-pathologic data to be collected and studied while validating based on biopsy findings in central pathology and clinical outcomes. The study is expected to enrol approximately 200 subjects for the Clarava™ and Tuteva™ validation. Verici Dx expects enrolment in these validation trials to complete by the end of 2021.

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About Verici Dx plc www.vericidx.com

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.