Franklin, TN – June 24, 2026 – Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, today announced it has received clinical laboratory accreditation from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP). The Company also received NY state approval of Tutivia™, its blood-based laboratory developed test (LDT) 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. By detecting rejection-associated biological mechanisms, 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.
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. With this New York state certification, Verici Dx is now authorized to provide laboratory testing services in all 50 U.S. states and the District of Columbia, creating nationwide availability of the Tutivia™ test.
“New York has established one of the most rigorous evaluation processes in the country for LDTs and the laboratories performing those tests,” said Sara Barrington, Chief Executive Officer of Verici Dx. “Receiving certification and test approval from the NYSDOH not only expands access to Tutivia™ for transplant centers in the state, it 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.”
Tutivia™ combines transcriptomics with proprietary machine learning algorithm to deliver predictive intelligence for acute kidney transplant rejection. The test provides clinicians with deeper insight to support more precise immunosuppression management by distinguishing rejection from other causes of graft injury, such as BK virus–associated nephropathy and ischemia–reperfusion injury, which can confound conventional blood tests including serum creatinine and cell-free DNA.
“Early identification of rejection biology, before clinical injury occurs, represents a meaningful advance in transplant medicine,” said Pablo C. Loarte-Campos, M.D., Nephrologist and Assistant Professor of Clinical Medicine, Weill Cornell Medical College. “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.”
The science underlying Tutivia™ was pioneered at The Mount Sinai Hospital in New York, one of the world’s leading transplant research centers. Its development is grounded in decades of clinical expertise and scientific rigor, and New York State approval represents a full-circle milestone, bringing a locally developed innovation back to the state’s transplant community with nationwide reach. “Tutivia™ is an example of how discoveries originating at Mount Sinai can be translated into technologies that improve patient care,” said Erik Lium, Ph.D., President of Mount Sinai Innovation Partners at the Icahn School of Medicine at Mount Sinai. “New York State approval is an important milestone that expands access to this innovation for transplant clinicians and patients across the country.”
“In addition to being grounded in rigorous science, the Tutivia™ test was validated in a clinical study that included a broad and diverse transplant patient population, giving clinicians confidence in its performance across the full spectrum of real-world cases,” said Lorenzo Gallon, M.D., Chair of the Verici Dx Scientific Advisory Board and Professor of Medicine and Surgery and Director of the Abdominal Organ Transplant Program at the University of Illinois, Chicago. “By delivering predictive intelligence that captures the biological complexity of transplant rejection, Tutivia™ aligns with how clinicians think and practice, particularly when managing high-risk patient populations.”
About Verici Dx
Verici Dx plc (AIM: VRCI) is a precision diagnostics company transforming care for transplant patients. The company combines multiomic analyses with proprietary artificial intelligence to deliver predictive, actionable, data-driven intelligence that reflects the complexity and heterogeneity of transplant patients, enabling clinicians to optimize therapy, guide biopsy decisions, and stratify risk with greater confidence. Operating at the intersection of laboratory and data science, Verici Dx develops complex models to answer the clinical questions that matter most with clarity and precision. All tests are built to rigorous scientific standards, validated across inclusive and real-world patient populations to ensure clinical relevance and reliability. Verici Dx’s lead product, Tutivia™, is a post-kidney transplant test focused on early detection of acute rejection. The company is headquartered in Cardiff for the UK, and in Franklin, Tennessee for the U.S. For more information, please visit https://vericidx.com/ and follow us on LinkedIn.
About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter, and YouTube.
