Welcome to the new Verici Dx blog and thank you for visiting. At Verici Dx, our objective is to improve outcomes for kidney transplant patients. Our first series of articles will explore the challenges for kidney transplant patients and their clinicians, demonstrate the importance of testing and prognosis, and highlight what we are doing to transform the industry.
Kidney transplantation is a life-changing procedure for patients with end-stage renal disease. In this debilitating disease, a patient’s kidneys can no longer support the body’s needs, with the patient likely requiring dialysis or a kidney transplant. Many patients spend years on the transplant list waiting for an appropriate match.
However, the journey of a kidney transplant recipient does not end in the operating room. The post-operative landscape is challenging, with the most daunting aspect being the risk of transplant rejection, where the recipient's immune system attacks the transplanted organ. It is a paradoxical situation, where the body's defence mechanisms can become its adversary. To this extent, we think of the kidney transplant as a “man-made disease” since it is our medical intervention that introduces the foreign organ into the body that triggers the reaction.
With anywhere up to 50% of kidney transplant patients experiencing a rejection symptom, this underscores the importance of testing post-transplant and understanding which patients are more likely to experience a rejection event, to allow clinicians to respond proactively. Without careful planning and treatment, the gift of a new kidney can be compromised.
Kidney Transplants and Rejection: Quick Facts
Understanding Kidney Transplant Rejection: Causes & Symptoms
There are primarily two types of rejection: acute and chronic.
The symptoms of kidney transplant rejection can be varied; common signs include:
A sudden rise in serum creatinine is a significant indicator at a biochemical level. These symptoms can sometimes be subtle, making regular check-ups and laboratory tests crucial.
Current Testing
Historically, the gold standard for detecting rejection has been a kidney biopsy. Under this procedure, a small sample of the transplanted kidney is extracted and examined under a microscope for signs of inflammation or damage. While biopsies offer definitive insights, they are invasive and potentially risky, time consuming, and can be burdensome for patients.
Blood tests that measure levels of creatinine are also used as elevated creatinine levels can be an early sign that the body is rejecting the transplanted kidney. Besides rejection, various complications can affect a transplanted kidney, such as infections or issues with the blood vessels or urinary tract connected to the kidney. Changes in creatinine levels can help detect these complications.
A common criticism of creatine-based testing is that it is not sensitive in early stages and not specific for rejection. Creatinine levels may not rise until significant kidney damage has occurred. This means that early stages of kidney dysfunction might go undetected. Creatinine levels might not immediately reflect acute changes in kidney function. This can be a limitation in rapidly evolving clinical situations. While a rise in creatinine can indicate transplant rejection, it is not specific to rejection. Infections, drug toxicity, or other kidney-related issues can also cause elevated creatinine levels.
There are also criticisms made about cell-free DNA (cfDNA) tests, which are more sensitive than creatinine but do not specify types of cell damage or causes. cfDNA tests measure the amount of donor-derived cfDNA (dd-cfDNA) in the bloodstream of the transplant recipient. An elevated level of the donor-derived cfDNA often indicates cell injury in the transplanted organ, possibly due to rejection, infection, or other causes of transplant injury. Elevated levels can be indicative of rejection, but they can also result from other factors such as infection, ischemic injury, or drug toxicity.
Given these limitations, Verici Dx is focused on the pursuit of less invasive and more precise diagnostic tools, aiming to ensure the longevity of the transplanted kidney and the well-being of the recipient. We aim to transform kidney transplant patient outcomes through our innovative and leading-edge precision tests.
Modernizing the field
Verici Dx’s first commercially launched product is Tutivia™. This is a post-transplant diagnostic focused upon acute cellular rejection including borderline rejection, which was commercially launched in January 2023. The data from the international, multi-center validation study for Tutivia™ demonstrated a significantly higher Positive Predictive Value (“PPV”) than currently available kidney transplant single blood tests, demonstrating that the test was able to provide clinicians with a call to action in their clinical care of patients. The test performed well against serum creatinine and is able to risk stratify patients in a meaningful manner – a high risk result from Tutivia was measured as a patient 6 times more likely to be rejecting than a patient with a low-risk score.
Our second product, Clarava™, is a pre-transplant prognosis test for the risk of early acute rejection. Clinical trials have shown it is the first pre-transplant prognostic test to enable measurement of a patient's immune response to assess the risk of early kidney graft rejection. As 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.
The Company is also working on a third product, Protega™, a liquid biopsy that aims to predict the risk of fibrosis and long-term graft failure. Together with Clarava™ and Tutivia™, this third product will allow Verici Dx to offer end-to-end testing for kidney transplant patients and their clinicians.
We hope this has provided some insights into why we believe kidney transplant patients deserve better, and how our tests are positioned to provide clinicians with the information they need. In our next article, we will explore the importance of early detection in more detail. Thank you again for reading our blog, please visit us at our website at vericidx.com to learn more and feel free to share this article as well.
