Verici Dx plc
("Verici Dx" or the "Company")
New York State clinical laboratory certification received
Nationwide access to Tutivia™ extended with authorisation to all 50 US states completed
Verici Dx Plc, (AIM: 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 ("CLEP").
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 ("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. 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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Verici Dx plc
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Sara Barrington, CEO |
Via Walbrook PR |
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Singer Capital Markets (Nominated adviser, Joint Broker) |
Tel: +44 (0)20 7496 3000 |
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Russell Cook / Alex Bond / Jalini Kalaravy |
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Oberon Capital (Joint Broker) |
Tel: +44 (0)20 3179 0500 |
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Mike Seabrook / Adam Pollock |
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Walbrook PR (Media & Investor Relations) |
Tel: +44 (0)20 7933 8780 or vericidx@walbrookpr.com |
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Alice Woodings / Rachel Broad |
Mob: +44 (0)7407 804 654 / +44 (0)7747 515 393 |
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VericiDx
VericiDx plc (AIM: VRCI) is a precision diagnostics company transforming care for transplant patients. The company combines multiomic analysis 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, VericiDx develops complex models that answer the clinical questions that matter most with unrivaled 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. VericiDx's lead product, Tutivia™, is a post-kidney transplant test focused on early detection of acute rejection.
The company is UK 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.