Our Professionals and Biological Systems at Verici Dx

Overview

RNA signatures decipher the body’s clinical messages to provide data driven insights to clinicians for focused and personalized care for their patients.

The RNA signatures are derived from biological systems such as inflammatory response, cell repair and cell metabolism that are highly predictive of identifying rejection requiring earlier clinical intervention.

Verici Dx offers an integrated suite of leading-edge tests forming a kidney transplant platform for personalized patient and organ response risk to assist clinicians in medical management for improved patient outcomes. Our approach is to develop patient-centric precision tools that reflect the complexity of the individual’s disease process rather than relying on clinical models from population-based generalizations. Our tests aim to be well balanced in terms of performance metrics whilst understanding the need for actionable data. The underlying technology is based upon artificial intelligence assisted transcriptomic analysis from pre-transplant to late stage post-transplant. The foundational research was driven by a deep understanding of transplant immunology and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.

Validation Study Design

Tutivia™ was studied as a prospective, multicenter (13 contributing transplant sites), blinded, international trial that allowed for the inclusion of diverse populations and broad diversity in care management practices; while allowing blinding to protect from the introduction of biases; thereby producing robust and reliable results for clinical integration.

The complexity of issues facing clinicians in their clinics was reflected as much as was possible in the study design.

Validation Study Results

151 total patient biopsies. For cause biopsies N=44 protocol biopsies N=107

BK can be difficult to differentiate from rejection in current biomarker testing.

Of the 151 patients in the validation set, 6 biopsies were determined to be BK positive through central and/or local pathology, all had a Tutivia™ score ≤50.

Patients with BK nephropathy (SV40+) were highly correlated with lower Tutivia™ results than those with negative SV40; C =.78.

74% Low-Risk and 26% High-Risk with a cut point > 50
Above this cut point, 60% High-Risk showed AR (PPV)
Below this cut point, 79% Low-Risk did not show AR (NPV)

When you receive a high-risk Tutivia™ result, the odds ratio of that patient having acute rejection (AR) is 5.74 over a low-risk result. This high odds ratio increases confidence in making informed treatment decisions.

Importance of a Risk Score

Tutivia™ utilizes a proprietary AI driven algorithm which produces a risk score from 0-100. Greater than 50 is interpreted as high risk for AR, while less than or equal to 50 is interpreted as low risk for AR.

Verici Dx translates a patient’s individual gene expression related to rejection to produce an overall patient risk score. This individualized risk score allows the clinician to shift focus to the single individual with that particular score at that particular encounter.