Verici Dx

Tutivia ™

Tutivia™ is a blood-based transcriptomic RNA signature that utilizes a proprietary algorithm to create an acute rejection risk assessment score in kidney transplant patients. For more information about Tutivia™ and the next-gen sequencing technology visit our website at vericidx.com, then click on the technology section at the top, then click on RNA signatures.

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

VericiDx is excited to announce that our Tutivia validation study is available as open access in the March American Journal of Transplantation.

Acute rejection often happens early. The Verici clinical publication reported:

  • 80% of clinically indicated biopsies were performed within 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 a single patient specific RNA expression blood test that may detect changes earlier in the disease course than later markers of injury such as serum creatinine and dd-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 to manage your patients. Tutivia demonstrates statistically significant improved performance in diagnosing acute rejection over serum creatinine, as well as being an independent predictor of acute rejection in combination with serum creatinine

When you receive a high-risk Tutivia™ result, the odds ratio of that patient having acute rejection (AR) is 5.74 over a low-risk result. This high odds ratio increases confidence in making informed treatment decisions.
Tutivia Delivers
Earlier Actionable Insights
  • Patient outcomes were defined by protocol (n=107) or for-cause (n=44) kidney biopsy.
  • Median time to biopsy and Tutivia risk score was 57 days, and a high risk score predicting acute rejection as early as 6 days post-transplant.
  • 80% of clinically indicated biopsies were performed within the first sixty days.
    • 69% of these had acute rejection by histopathology.
    • 83% of early biopsies with pathologic acute rejection had a high Tutivia risk score.
Personalized
  • Tutivia utilizes a proprietary RNA gene expression signature with an algorithm to generate a risk score for acute rejection (AR).
  • A patient with a Tutivia high-risk score is nearly 6 times more likely to be experiencing an acute rejection compared to a patient with a low-risk score.
  • Tutivia can differentiate acute rejection from BK nephropathy; patients with a positive SV-40 stain on kidney biopsy were highly correlated to a very low Tutivia risk score.
Dynamic
  • The RNA signature is derived from dynamic biological systems involved in the inflammatory response, the interplay of immune cells involved in transplant rejection, and genes involved in cell repair and metabolism in the kidney.
  • The Tutivia signature algorithm was derived utilizing machine learning techniques to identify and estimate an individualized patient’s risk of AR.
Reliable
  • Tutivia was validated in a prospective, international, multicenter, blinded observational study with a broadly diverse patient population and a full range of kidney donors.
  • The study outcomes evaluated patients for the full spectrum of acute rejection, including borderline, utilizing BANFF 2019 criteria.
  • Tutivia testing is performed in the fully accredited Verici Dx clinical laboratory under rigorous quality assurance program.

The data to inform, the drive to earn trust.

Verici Dx partners with clinicians and their patients to offer a platform of single and related tests to improve patient care over the course of their transplant journey.

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An innovative path to better outcomes.

We are singularly focused on providing insights to inform the path to successful transplant outcomes for patients.

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Driven by curiosity. Delivered by science.

The drive to innovate and develop the suite of Verici Dx diagnostic products is spearheaded by our experienced molecular scientists and highly qualified bioinformaticians alongside AI machine learning technology...

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Next gen, next level.

Verici Dx is a developer of advanced clinical diagnostics in organ transplant based upon the patient’s own biological systems.

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A solid foundation.

Verici Dx products and solutions are underpinned by extensive scientific research enabled by access to expertly curated collaborative studies.

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We believe in partnerships.

Meaningful change happens through collaboration. Improving patient care takes a community. We champion groups devoted to collective, collaborative change.

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driven by curiosity.

delivered by science.

PTRA ™

PTRA™ (Pre-Transplant Risk Assessment) , formerly known as Clarava, is the first pre-transplant prognostic test to assess a patient's immune phenotype for the probable risk of early kidney graft rejection. The validation study represents a significant demonstration of PTRA™ as a predictive test capable of informing a clear, actionable response from clinicians. Verici Dx has licensed PTRA to Thermo Fisher (One Lambda) for commercial availability sometime in 2024.

The PTRA™ study, which included a broad and diverse group of 122 patients preparing to receive a deceased donor (DD) kidney transplant with a range of rejection outcomes across 13 centers, demonstrated a statistically significant AUC result of 0.719, P = 0.013, with a sensitivity of 78% and specificity of 64%, identifying patients that are at increased risk for a kidney rejection event in the critical first 60 days post-transplant. Study data analysis of the clinical performance of PTRA™ demonstrated differentiation of high-risk and low-risk patient groups, determining that patients of high risk were approximately six times (OR = 6.133) more likely to have a rejection than those of low risk.

Whilst DDs provide the majority of kidney transplants, the Company will be also be exploring further samples drawn from Living Donor (LD) transplant recipients, in addition to assessing the anticipated combination of using our pre-transplant test, PTRA™ in conjunction with our post-transplant test, Tutivia™.

PTRA™ is the only pre-transplant test of its kind that can risk stratify patients based on their likely immune response to a transplanted organ. This allows clinicians to identify patients most likely to require increased monitoring, including adjustments in the type, dose, and duration of immunosuppressive agents. Existing approaches to assess rejection risk are standardized and typically based on the recipient's race, age, previous transplant history and whether they have antibodies against common donor antigens. As reported, the PTRA™ personalized risk assessment is especially important for the expanding DD transplant population.

For more information about PTRA you can contact Drew Silverman at dsilverman@vericidx.com.

Verici Dx is a developer of a complementary suite of leading-edge technology, forming a kidney transplant platform, to assist clinicians’ ability to improve patient outcomes from pre-transplant throughout the post-transplant period. The underlying technology is based on artificial intelligence-assisted transcriptomic analysis. We are committed to partnering with transplant clinicians, to impactfully change the quality of life for kidney transplant patients, and the longevity of kidney grafts globally.

Personalized Testing for Patient Care

Verici Dx kidney transplant tests use next-generation sequencing to define a personalized, precise risk-profile of each patient over the course of their transplant journey, as well as detecting injury in advance of current clinical and pathological tests.

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