Verici Dx (VRCI ) announced this morning that it has expanded the scope of its licence agreement with the Icahn School of Medicine at Mount Sinai Health System ("Mount Sinai"), New York City's largest academic medical system, to include an additional patent filing.
The developer of advanced clinical diagnostics for organ transplants said the additional patent filing relates to the analysis of gene expression in a blood-based test (liquid biopsy) to predict the risk of fibrosis (chronic kidney graft damage) and the rejection of the graft.
Interstitial fibrosis and tubular atrophy is a significant complication in 50-65% of transplants at 12-24 months and a major cause of graft rejection in the first year after transplantation.
Verici said developing a product that can predict risk of fibrosis and rejection using its core technological approach will extend its portfolio across the full course of a patient's transplant journey and complement its two flagship in vitro diagnostic assays, Clarava™ and Tuteva™.
Clarava™ is a pre-transplant prognosis test for the risk of early acute rejection, and Tuteva™ is a post-transplant diagnostic focused upon acute cellular rejection. It said a further product focused fibrosis risk would ‘support the diagnosis of risk of longer-term graft failure as well.’
Verici said the development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis ‘fits well’ with its current laboratory capabilities, instrumentation and expertise.
Liquid biopsy also allows for easier deployment in clinical care given the limited population of transplant centres that undertake tissue allograft surveillance biopsies and the lower risk and costs associated with blood-based biopsies.
Verici detailed that its multi-centre observational clinical study used to validate the clinical performance of Clarava™ and Tuteva™ ‘will also include patients being assessed for fibrosis for an extended study period beyond the initial end points for the first two products in order to collect data in support of validation for this newly licensed test to predict risk of fibrosis.’
"The development of a product that can predict the risk of long-term graft failure, alongside our flagship products Clarava™ and Tuteva™, would establish an end-to-end solution for clinicians seeking to understand how a patient will and is responding to organ transplant.
There is a critical need for more personalised diagnostic information within transplant care, and in particular technologies informing earlier interventions with anti-fibrotic therapies in advance of irreversible organ damage,” commented Sara Barrington, CEO of Verici Dx.
Shares in Verici Dx have skyrocketed by over 75% since the company was admitted to Aim in November 2020 to open this morning at 62.5p following the announcement and moving up to 63.5p in early trading.
Reasons to Follow VRCI
Verici Dx is a company developing and commercialising tests in order to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants.
Industry Leading IP
Its work is 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.
Meanwhile, the company’s 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.
Verici Dx was admitted to trading on the AIM market on 3 November 2020, with the company also raising £12.05m through an oversubscribed fundraising,to primarily fund the development and commercialisation of its two leading clinical products in the kidney transplant space.
Significant Market Opportunity >$600m p.a.
The waiting list for transplants is significant at approximately 300,000 globally with both US and European governments calling for an acceleration in the number of transplants undertaken each year.
Globally, there are approximately 95,000 transplants per annum, of which approximately 24,000 and 25,000 are performed in the US and Europe respectively.
In the US the average cost of a transplant is $0.44m per transplant and the average annual cost of dialysis is around $0.09m, with patients faced with being on dialysis from 3 to 5 years.
Development Newsflow
Verici aims to commence a multi-centre validation study for each product in 4Q20, with studies expected to conclude in 4Q21. Clarava and Tuteva are then expected to be offered as Lab Developed Tests with regulatory approval with first revenues expected during 2022.
Verici expects supportive news flow throughout 2021 on commercial partnerships, regulatory news, reimbursement and results from test development programmes. Once approved, it aims to accelerate reimbursement coverage ahead of full clinical utility data in 4Q22.
Follow News & Updates from Verici Dx here: