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Further data from Tuteva™ clinical validation study presented

Performance in blinded multi-centre trial establishes new industry standard in detection of acute kidney transplant rejection and paves way for US commercial launch in 2022

Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that the additional data from its blinded, international, multi-centre validation study for Tuteva™, the Company’s post-transplant blood test focused on acute rejection, has been presented at the American Transplant Congress (“ATC”) earlier this month.

The further data demonstrates a Positive Predictive Value (“PPV”) of 60% and Negative Predictive Value (“NPV”) of 80% for Tuteva™, a next-generation RNA sequencing assay. This and the ability to detect all types of rejection support improved clinical diagnosis compared to that currently available from other kidney transplant blood tests without enhancement from clinical features, and in a broad validation population. This data confirms that Tuteva™ demonstrates strong performance in the detection of acute rejection, following a kidney transplant. These clinically important results position Tuteva™ for an on-schedule commercial launch later this year to support the estimated c. 100,000 global patients who undergo kidney transplant procedures annually.

The study design and successful outcomes were well received at ATC and the poster, presented at the Congress and referenced during the closing session of the “What’s new / What’s hot” roundup, is now available on the Company website here:

Further details can be seen in the poster, but key conclusions from the study are outlined below:

  • Validation in an all-comers cohort 1 that is independent of the training set and representing all forms and levels of rejection is essential to assessment of expected test performance in translational clinical care settings to support medical management decision making.
    1 The validation study utilised a generalised ‘all-comers’ patient population rather than a specific subgroup. The Tuteva™ study was purposefully designed this way to capture the clinical reality of all types of rejection, including sub-clinical, borderline, T Cell-mediated, and antibody-mediated rejection across 14 international transplant centres. The results reflect the wide clinical applicability of the test for comprehensive commercial adoption in a real-world setting.
  • Prospective, multicenter, international studies allow for the inclusion of diverse populations and broad diversity in care management practices while allowing blinding to protect from introduction of biases; thereby producing robust and reliable results for clinical integration.
  • Tuteva is a quantitative blood-based transcriptomic signature able to correlate an acute rejection risk score with rejection phenotype based on histopathology in the kidney biopsy, representing a level of evidence which has not yet not existed in biomarker transplant biology.

The trial continues for new validations of other pre and post-transplant tests which are included in the trial objectives, and patients will be monitored in-study at local sites for two years. Further data will be useful in supporting the utility of Tuteva TM and its apparent ability to also track changes in rejection status, as appeared to be shown by the test and biopsy results of a sub-group of 12 patients in the sample who received multiple biopsies. Should additional data support this finding in a larger sample over time, it will confirm that Tuteva TM is measuring relevant rejection markers reliably over time, which is important for clinical monitoring.

Sara Barrington, CEO, Verici Dx, said: “I’m delighted that the data shows that our underlying technology has the potential to be clinically groundbreaking, particularly as we focus on commercial launch later this year with the goal of making this much needed test available to all kidney transplant patients, so that an earlier clinical diagnosis can better inform their medical management.”

The publication of this data follows on from the recently announced senior appointments of Grant Harvey and Dr. Windy Tucci as Business Development Director and Medical Science Liaison Director respectively, to further strengthen the Verici Dx team ahead of planned commercial launch later this year.

In addition, Verici Dx expects to announce multi-centre clinical validation results for Clarava™, the pre-transplant prognostic test this summer, having completed additional tissue type matching analysis to support the data evaluation.



Sara Barrington, CEO
Julian Baines, Chairman
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