Worldwide exclusive licence to liquid biopsy IP for predicting risk of fibrosis and chronic damage rejection
Strengthens patent portfolio covering the entire kidney transplant diagnostic pathway
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has expanded the scope of its licence agreement with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”) to include an additional patent filing related to the analysis of gene expression in a blood-based test (liquid biopsy) to predict risk of fibrosis (chronic kidney graft damage) and rejection of the graft.
Interstitial fibrosis and tubular atrophy (IF/TA) is a significant complication in 50-65% of transplants at 12-24 months1 and a major cause of graft rejection in the first year after transplantation2.
The development of a product that can predict risk of fibrosis and rejection using the Company’s core technological approach would extend Verici Dx’s portfolio across the full course of a patient’s transplant journey and complement the Company’s 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. A further product using this technological approach and focused on risk of fibrosis would support the diagnosis of risk of longer-term graft failure as well.
The development of a novel blood-based immune-phenotyping prognostic test for risk of fibrosis fits well with Verici Dx’s 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.
The Company’s multi-centre observational clinical study 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.”
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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.
The prognostic test described is based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai has a financial interest in Verici Dx.
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians in the top 1% of all physicians nationally by U.S. News & World Report.