Tutivia™

Tutivia™ deciphers the body’s clinical messages in response to the transplanted kidney in the form of a biomarker test. This provides non-invasive early data designed for all types of patients and all types of rejection so that clinicians can personalize their care for patients.

Overview

Early and non-invasive

Tutivia™ is a blood-based biomarker test to identify risk of acute rejection, including subclinical and borderline, early in the process anywhere in the first year after transplant.

Dynamic and personalized

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

One test, all patients, all types of rejection

Tutivia™ is the only complete test for all types of rejection, and is able to differentiate from other clinical issues such as BK nephropathy.

What comes with the test

Sample Collection Kit
Routine Blood Draw
Ship to Verici Laboratory
Easy to Understand Results

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.
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Clinical Study

All evaluable participants (n = 151) enrolled at 13 contributing centers in 5 countries were included in the Tutivia™ validation. Each study participant had blood collected at the time of for-cause (n = 44) or protocol biopsy (n = 107) within the first 6 months following transplant. Each biopsy was read centrally by an expert in renal pathology to identify and characterize rejection phenotypes. In 151 unique patients, 46 (30%) rejection events were characterized according to current (2019) BANFF criteria, including borderline TCMR3. Mean time to rejection was 61.1 days; range: 6 - 175d. Additionally, BK Nephropathy was identified in 6 patients and pyelonephritis in 3 patients.

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 set. 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. 

Tutivia™ is a blood-based transcriptomic RNA expression signature that utilizes a proprietary AI algorithm to assign a risk score for acute rejection with correlation to kidney biopsy, across the entire BANFF 2019 histological continuum. Tutivia™ is able to assist the clinician in actionable decisions, regarding treatment of kidney transplant patients at risk for acute rejection.
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