Know the risk. Get to know Tutivia.™

Can you tell which one of these patients is at high risk for acute rejection after their kidney transplant?

Tutivia™ is a blood-based proactive risk assessment tool for acute rejection in your kidney transplant patients. Tutivia™ uses RNA sequencing technology that helps answer your questions to deliver a more patient-centric care plan.

Which of my patients is at high risk for acute rejection?

How do I know if a patient has Acute Rejection (AR) or BK Nephropathy (BKN)?

How do I manage patients with Delayed Graft Function (DGF)?

Why Tutivia™?

When a patient receives a high-risk Tutivia™ result, the hazard ratio of that patient having AR is 5.74 over a low-risk result.

The high hazard ratio increases confidence in making informed treatment decisions.

1 Loupy A, Haas M, Roufosse C, et al. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell– and antibody-mediated rejection. Am J Transplant. 2020;20:2318–2331.
https://doi.org/10.1111/ajt.15898

When Tutivia™?

151 TOTAL PATIENT BIOPSIES
(INDICATION BIOPSIES N=44 | PROTOCOL BIOPSIES N=107)

HIGH SENSITIVITY IN INDICATION BIOPSIES EVEN WITHIN 60 DAYS POST TRANSPLANT

RNA signatures offer precision as early as first week post-transplant as they are not markers of injury that may be confounded by the initial surgery.
Offering an early ability to risk stratify your patients offers you an opportunity to manage your patients proactively.

BKN

BK can be difficult to differentiate from rejection.
In the clinical validation study, the BKN patients returned a low risk for AR result.
This differentiation may be important in your clinical decision making.

DGF

DGF presents clinically challenging complications post transplant.
Click here to learn the role of Tutivia™ in patients where DGF may be suspected.

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.