Clarava™ is the first pre-transplant prognostic test to assess a patient's immune phenotype for the probable risk of early kidney graft rejection.
The validation study represents a significant demonstration of Clarava™
as a predictive test capable of informing a clear, actionable response from clinicians. Verici Dx is on track to make Clarava™
available by early 2024.
study, which included a broad and diverse group of 122 patients preparing to receive a deceased donor (DD) kidney transplant with a range of rejection outcomes across 13 centers, demonstrated a statistically significant AUC result of 0.719, P = 0.013, with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 days post-transplant. Study data analysis of the clinical performance of Clarava™
demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times (OR = 6.133) more likely to have a rejection than those of low risk.
Whilst DDs provide the majority of kidney transplants, the Company will also be exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, Clarava™
in conjunction with our post-transplant test, Tutivia™
is the only pre-transplant test of its kind that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient's race, age, previous transplant history, and whether they have antibodies against common donor antigens. As reported, the Clarava™
personalized risk assessment is especially important for the expanding DD transplant population.