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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.

What Comes with the Sample Collection Kit

Corrugated shipper and polystyrene cooler
PAXgene blood RNA tube
Discard tube
Protective absorbent tube sleeve
Biohazard bag with an outside pocket for the requisition form
Requisition form
Sample draw, processing, and shipping instructions