Verici Dx plc (LON:VRCI), a developer of advanced clinical diagnostics for organ transplant, has announced it has been granted a CPT® Proprietary Laboratory Analyses (PLA) code1,2 for its Protega test by the American Medical Association (AMA). The new code, X257U, has been approved and published by the AMA Editorial Panel and are scheduled to become effective on October 1, 2026.
Patti Connolly, COO of Verici Dx, said: “We were delighted with the AMA’s decision as CPT® codes are fundamental in the commercialisation of Protega.”
Reimbursement in the US is comprised of three components: code, price and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® PLA code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.
Notes:
1. Current Procedural Terminology (CPT) codes are medical codes that are used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies and accreditation organizations. CPT codes are also used for administrative management purposes such as claims processing and developing guidelines for medical care review.
2. PLA codes are CPT codes including a corresponding descriptor for laboratories or manufacturers that want to identify their test more specifically.
Verici Dx Plc has also announced the publication of a health economic cost impact analysis demonstrating the significant potential cost benefit of the Pre-Transplant Risk Assessment (“PTRA”) test for predicting early acute rejection (“EAR”) in kidney transplant. The study, titled ‘Cost Impact of a Novel Pre-transplant Risk Assessment Tool for Early Acute Rejection in Kidney Transplant Patients‘ was conducted by Avalon Health Economics and has been published in the Journal of Health Economics and Outcomes Research. The PTRA test is commercially marketed by Thermo Fisher Scientific*.
The study shows that integrating PTRA™ into standard clinical practice could generate substantial healthcare savings while also supporting more personalised immunosuppression strategies for patients. Key findings of the study include the potential for more than $191 million in healthcare savings across the U.S. standard-risk kidney transplant population over two years.
The authors also note that more intense immunosuppression is often used in patients without clear low risk patient characteris-tics. Based on their study, the authors conclude that incorporating the PTRA test in standard-of-care protocols may allow clinicians to more confidently tailor immunosuppression at a reduced level, reducing medication-related adverse events and unfavourable clinical outcomes. The approach may also allow for more intense immunosuppression for some patients with a high-risk PTRA result, reducing acute rejection and its subsequent effects.
*The Pre-Transplant Risk Assessment (PTRA) test is a laboratory developed test, and its performance characteristics determined by the CLIA laboratory performing the test. It has not been cleared or approved by the U.S. Food and Drug Administration or CE marked in the EU.
Beatrice Concepcion, MD, Medical Director, Kidney and Pancreas Transplant, University of Chicago Medicine said: “Early acute rejection remains one of the most significant drivers of post-transplant complications, graft injury, and healthcare costs. Having the ability to stratify rejection risk before transplantation could meaningfully change how we approach immunosuppression. The PTRA test has the potential to help clinicians personalize therapy, escalating treatment for patients who truly need it while avoiding unnecessary exposure in lower-risk patients.”
Sara Barrington, Chief Executive Officer of Verici Dx, said: “Kidney transplant recipients require carefully managed immunosuppressive therapy to prevent rejection while minimizing complications due to immunosuppression associated infections, adverse drug events, or malignancies. However, clinicians currently lack robust tools to accurately stratify patient risk for early rejection prior to transplantation. This publication highlights the substantial value that a precision diagnostic like PTRA can bring to transplant medicine, supporting more informed clinical decisions, improving patient management, and potentially saving the healthcare system millions of dollars.”
