Verici Dx has built a three-product kidney transplant diagnostics portfolio designed to assess patient risk before transplantation and monitor major complications after surgery.
The portfolio consists of Clarava, Tutivia and Protega, with each test addressing a different stage of kidney transplant care. Clarava assesses the risk of acute rejection before transplantation, Tutivia identifies acute rejection risk after transplantation, and Protega assesses the risk of progressive fibrosis in the transplanted kidney.
Together, the products give Verici Dx coverage across several important stages of the transplant pathway rather than focusing on a single complication or point in patient care.
Clarava is the earliest-stage test in that pathway. It uses an RNA gene signature to help determine an individual patient’s risk of acute rejection during pre-transplant assessment.
Current approaches to assessing rejection risk before transplantation can use broad factors such as recipient age, retransplantation, race and the presence of antibodies against common donors. Clarava adds a patient-specific molecular assessment that could help clinicians determine the appropriate level of immunosuppression more precisely.
The test is designed for patients who have already been listed for a kidney transplant and provides information before surgery takes place. This gives Verici Dx a role at the pre-transplant stage, where treatment planning and risk assessment begin.
Following transplantation, Tutivia addresses the risk of acute rejection.
Tutivia is a blood-based test that uses a transcriptomic RNA expression signature and a proprietary artificial intelligence algorithm to produce an acute rejection risk score from zero to 100. A predetermined cut-off of 50 separates patients into lower and higher risk categories.
The test was evaluated in a prospective, blinded international validation study involving 151 kidney transplant patients across 13 transplant centres in five countries. Blood was collected at the time of protocol or for-cause biopsies during the first six months after transplantation.
Among the 151 patients, 46 rejection events were identified according to BANFF 2019 criteria, including borderline T-cell mediated rejection. Patients receiving a high-risk Tutivia result had a 5.74 times higher hazard of acute rejection than those receiving a low-risk result.
Tutivia also identified acute rejection from as early as six days after surgery and showed 83% sensitivity, identifying 20 of 24 cases where a for-cause biopsy was performed within 60 days of transplant. This early assessment is central to the product’s role. RNA signatures can provide information from the first week following transplantation without relying on injury markers that may be affected by the surgery itself.
Protega extends Verici Dx’s post-transplant offering beyond acute rejection and into the risk of progressive fibrosis.
Fibrosis involves progressive scarring in the transplanted kidney and is primarily assessed through histological analysis of kidney biopsies. Protega provides an additional blood-based measure of the likelihood that fibrosis will develop or progress.
The prognostic assay analyses multiple RNA biomarkers from peripheral blood following kidney transplantation and produces a risk score between zero and 100. A clinically validated cut-off classifies recipients as being at either lower or higher risk of developing progressive fibrosis under BANFF 2019 criteria.
The three-product structure gives Verici Dx coverage across several clinical decision points within the same patient pathway. Clarava addresses risk before surgery, Tutivia addresses acute rejection after transplantation, and Protega addresses the risk of progressive tissue damage.
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.
