tutivia™

Overview

You have high standards, so do we.

You expect more from biomarkers, Tutivia™ delivers.

Tutivia™ is a single test using RNA signature technology, to assist you in taking your patient's personalized post kidney transplant care to the next level.

To view our publication on Tutivia™, Prospective observational study to validate a Next Generation Sequencing blood RNA signature to predict early kidney transplant rejection, please click on the following link

read the article here

Earlier insights for
proactive care:

Tutivia™ is the only blood test for acute rejection that can be used at any time, even in the first week after transplant.

Personalization to dynamically inform treatment desicions:

Tutivia™ differentiates transplant rejection from BK nephropathy and generates a patient-centric risk score rather than one derived from generalized population-wide indications.

Reliable testing for
all your patients:

Uniquely Tutivia™ is validated in a broadly diverse clinical patient population, with a full range of kidney donors and recipients, to produce a robust results using a data-driven risk score.

You want earlier insights for proactive care - Tutivia™ makes it possible

Acute rejection often happens early.

The Verici Dx clinical data reported:

+ 80% of clinically indication biopsies were performed in the first 60 days.
+ 69% of these early biopsies showed acute rejection (AR).
+ 83% of early biopsies showing AR had a high Tutivia™ risk score.

Tutivia™ is designed to be a single blood test detecting RNA expression changes earlier in the disease course than later markers of injury such as cfDNA.

Tutivia™ can be used as early as the first week after the transplant.

Tutivia™ provides a patient-centric risk score that can be used proactively and demonstrates statistically significant improved performance over serum creatinine while being an independent predictor in combination with serum creatinine.

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.

To expand on the statement above, early evidence shows Tutivia™ has the ability to differentiate between BK nephropathy and acute rejection. In our validation study, 6 cases of BK virus were identified without raising risk score for rejection. Illustrating a promising impact on treating patients where BK is suspected.

Early evidence also illustrates Tutivia™ was able to identify acute rejection as early as 6 days. In addition, Tutivia™ had an 83% sensitivity (20/24) in identifying rejection when a for cause biopsy was done <60 days post-transplant. This early indicator helps establish a reference point for future testing.

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 absence of rejection on histopathology findings in 79% 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.