FRANKLIN, Tenn., June 24, 2026
Verici Dx plc announced that it has received clinical laboratory accreditation from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) along with New York State approval for Tutivia™, its blood-based laboratory developed test (LDT) designed to predict the risk of acute kidney transplant rejection. The milestone authorizes Verici Dx to provide Tutivia testing across all 50 U.S. states and the District of Columbia, expanding access to one of the country’s largest and most active kidney transplant populations.
Tutivia™ Provides Predictive Intelligence for Early Rejection Detection
Tutivia™ combines transcriptomic analysis with Verici Dx’s proprietary machine learning algorithms to generate an easy-to-interpret risk score that classifies kidney transplant recipients as either low or high risk for acute rejection. Rather than measuring tissue injury after damage has occurred, the test identifies rejection-associated biological mechanisms before clinical deterioration becomes evident. This enables clinicians to optimize immunosuppressive therapy, guide biopsy decisions, stratify patient risk, and potentially reduce unnecessary biopsies while helping prevent graft loss.
New York Certification Validates Clinical Performance and Laboratory Standards
New York operates one of the nation’s most rigorous laboratory evaluation and approval programs for laboratory developed tests. The certification provides independent validation of Verici Dx’s laboratory operations, data science capabilities, and clinical performance while extending the company’s testing services nationwide. The approval is particularly significant given that more than 2,000 kidney transplants were performed in New York during 2025, making the state one of the largest transplant markets in the United States.
Advertisement
Precision Diagnostics Advance Kidney Transplant Care
Tutivia™ is designed to distinguish acute rejection from other causes of kidney graft injury, including BK virus-associated nephropathy and ischemia-reperfusion injury, conditions that often complicate diagnosis using conventional biomarkers such as serum creatinine and cell-free DNA. The underlying science for the test originated at The Mount Sinai Hospital, with its clinical validation including a diverse real-world transplant population to ensure broad clinical applicability. With nationwide availability now established, Verici Dx aims to support transplant centers across the U.S. with predictive, AI-driven diagnostics that improve clinical decision-making and patient outcomes in kidney transplantation.
Source: Verici Dx press release
