Verici Dx has received New York State approval for Tutivia, its blood-based laboratory developed test for assessing the risk of acute rejection in kidney transplant patients. The approval also includes clinical laboratory accreditation, enabling the company to offer Tutivia across all 50 US states and the District of Columbia.
The decision gives Verici Dx full national access in the US for a test aimed at improving post-transplant monitoring. New York has a demanding approval process for laboratory developed tests, so clearance in the state is a meaningful step for the company’s regulatory and commercial position. It removes a key access barrier and allows Verici Dx to reach transplant centres in one of the country’s largest kidney transplant markets.
Tutivia is designed to identify patients at low or high risk of acute rejection after a kidney transplant. The test uses a blood sample, transcriptomic analysis and Verici Dx’s machine learning technology to generate a clear risk score. The aim is to give clinicians earlier insight into rejection risk before serious graft damage becomes evident.
Acute rejection can be difficult to assess using standard measures alone. Markers such as serum creatinine and cell-free DNA may be affected by other causes of graft injury, including BK virus-associated nephropathy and ischemia-reperfusion injury. Tutivia is designed to help distinguish acute rejection from these conditions and reduce uncertainty in patient management.
The approval supports Verici Dx’s plan to build wider use of its AI-driven transplant diagnostics platform. With nationwide availability now in place, the company can engage more transplant centres and offer a test that may help guide monitoring, biopsy decisions and immunosuppressive treatment. A clearer risk profile may support more targeted care for patients after transplant.
New York is also commercially relevant. More than 2,000 kidney transplants were performed in the state during 2025. Access to this market gives Verici Dx a larger base for potential adoption at a time when transplant programmes continue to seek better tools for early rejection assessment.
Verici Dx Plc (LON:VRCI) is developing a complementary suite of proprietary, leading-edge tests forming a kidney transplant diagnostics platform for personalised patient and organ response risk to assist clinicians in medical management for improved patient outcomes.
