Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces it has entered into a Material Transfer Agreement (“MTA”) with the Icahn School of Medicine at Mount Sinai and Principal Investigator Dr. Peter Heeger, to allow access to samples from the CTOT-19 (Clinical Trials in Organ Transplant1) trial in an effort to validate the performance and development of commercial tests designed to improve short and long-term graft and patient survival.
The Company has secured an agreement, providing access to de-identified samples generated from participants in the CTOT-19 study, titled: “Effects of Inhibiting at Early Inflammation in Kidney Transplant Patients.”2 This randomised controlled trial was initiated in November 2015 with the aim to enrol 300 kidney transplant recipients at 15 transplant centres in the US and Canada, with a primary completion date expected July 2021.
Access to samples from this important clinical trial, in addition to the Verici Dx clinical study already ongoing for the validation of Clarava™ and Tuteva™, provides the Company with a large and well-characterised sample group. The Company’s laboratory will conduct a blinded evaluation of samples in Clarava™ and Tuteva™ and work with investigators, including Dr. Peter Heeger, to characterise results following the data lock later this year. The Company will further support this important CTOT programme by providing full transcriptomic sequencing to the investigators to augment ongoing research in mechanistic studies.
Dr. Barbara Murphy, Chair of Science Advisory Board of Verici Dx, commented: “We are extremely pleased for the opportunity this MTA represents and to collaborate with Dr. Peter Heeger and CTOT. We look forward to the assessment of the clinical performance validation of both Clarava and Tuteva as laboratory developed tests and to furthering research endeavours in organ transplant.”
The test described is based on technology developed by Mount Sinai faculty and licensed to Verici Dx. Mount Sinai and the Mount Sinai faculty who developed this technology, including Dr. Barbara Murphy, have a financial interest in Verici Dx.
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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.
About Mount Sinai Health System
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.