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Tutivia™ Validation Study

Clinical Data

Verici Dx Clinical Study

Verici Dx has conducted an observational global clinical study to assess the correlation of the blood-based gene expression signatures of the organ recipient with outcomes related to kidney injury, acute rejection, fibrosis, or graft loss. We will examine the information of the full transcriptome and leverage the ability of analytical algorithms and machine learning to enhance the utility of gene expression signatures in guiding the interpretation of risk results.

The target of 550 patients enrolled at 16 centers in 6 countries will be used to validate by all Tutivia™, Clarava™ and Protega™.

How was Tutivia™ Studied?

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.
VERICIDx STUDY DESIGN
INCLUSION CRITERIA
  • Individual recipients of living or deceased donor kidney transplant
  • Age: ≥ 18 ≤ 80
  • High risk donor organs 
  • Patients with class 1 or class 2 DSA 
  • Signed informed consents
EXCLUSION CRITERIA
  • Recipients of multiple organ transplant, except kidney-pancreas transplant
  • Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
  • HIV or Hepatitis C positive patients
  • Pregnant women
Tutivia™ Clinical Validation Study Demographics

Actionable Data

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. We used artificial intelligence assisted analysis to provide RNA signatures focused upon the immune response and other biological pathway signals critical for transplant prognosis of risk of injury, rejection and graft failure. 
Tutivia™ AR Event Chart

Tutivia™ risk scores are calculated continuously from 0-100; for interpretation, a pre-determined risk cut-point of 50 was established based on the independent training set1. The risk score distribution (fig. 1) resulted in 26.5% of patients with a high risk (>50) score result in which 60% were shown to correlate with rejection on histopathology; low risk score results in 73.5% of patients correlated with an absenceof rejection on histopathology findings in 80% of patients. The receiver operating characteristic curve AUC was 0.693, P<0.001.

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