Verici Dx secures New York State laboratory certification for Tutivia test

VRCI

Verici Dx Plc (LON:VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has received clinical laboratory certification from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program.

Having achieved New York state certification, the nation’s most rigorous laboratory evaluation program, Verici Dx has now completed its full authorisation to provide laboratory testing services in all 50 US states and the District of Columbia, creating nationwide availability of the Tutivia™ test. New York is one of the most active kidney transplant locations in the country, with more than 2,000 transplants performed in 2025, underscoring the importance of access to Tutivia™ for clinicians managing complex, high-acuity patients.

The Company also received state approval for Tutivia™, its blood-based laboratory developed test that delivers predictive, data-driven intelligence in the form of an easy-to-interpret risk score classifying patients as low or high risk of acute rejection of the kidney transplant. The Tutivia™ test provides clinicians with a proactive indicator of rejection risk, enabling more precise patient management and risk stratification, better-timed interventions, and the potential to reduce avoidable biopsies and graft loss.

Pablo C. Loarte-Campos, M.D., Nephrologist and Assistant Professor of Clinical Medicine, Weill Cornell Medical College, said: “Early identification of rejection biology, before clinical injury occurs, represents a meaningful advance in transplant medicine. Unlike single-parameter tools such as cell-free DNA that are non-specific, lagging indicators measuring downstream injury, Tutivia™ reflects the biological complexity of transplant patients, enabling sensitive and selective identification of rejection and distinction from other causes of graft dysfunction. New York State approval expands access to this testing for a large and clinically complex transplant population, including high-risk patients for whom conventional biomarkers are often insufficient.”

Sara Barrington, Chief Executive Officer, said: “New York has established one of the most rigorous evaluation processes in the country for LDTs and the laboratories performing those tests. Receiving certification and test approval from the NYSDOH not only expands access to Tutivia™ for transplant centres in the state but also provides independent validation of our laboratory and data science operations and clinical performance. This milestone ensures our ability to support clinicians nationwide with the predictive intelligence they need to proactively manage complex transplant cases.”

Erik Lium, Ph.D., President of Mount Sinai Innovation Partners at the Icahn School of Medicine at Mount Sinai, said: “Tutivia™ is an example of how discoveries originating at Mount Sinai can be translated into technologies that improve patient care. New York State approval is an important milestone that expands access to this innovation for transplant clinicians and patients across the country.”

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