Verici Dx, a developer of clinical diagnostics for organ transplant, has seen successful validation results from its prospective, blinded, clinical validation study for Clarava, a pre-transplant prognostic test to measure a patient’s immune response and assess the risk of early kidney transplant rejection.
The test is based on RNA sequencing and uses artificial intelligence to work out an RNA signature from gene expression. Using just a simple blood draw, it will help clinicians to treat an estimated 65,000 eligible patients each year upon its commercial launch before the end of 2023.
Sara Barrington, CEO of Verici Dx, said: “It’s a fascinating new development in medical care and diagnostics. One of the things that we emphasize about RNA signatures is that it’s starting to move down a personalized medicine route.”
“It is a very informative and dynamic approach to what the patient’s body trying to tell the clinician. And that’s why we’re enthusiastic about this approach, and why we think it’s very dynamic and specific to the patient.”
The Clarava study included 122 patients from broad and diverse backgrounds preparing to receive a kidney transplant, with a range of rejection outcomes. The study was conducted across 13 centres in the US, Europe, and Australia. It demonstrated a sensitivity of 78% and specificity of 64%, identifying patients at increased risk for a kidney rejection event in the critical first 60 to 90 days post-transplant after receiving a kidney from a deceased donor.
Analysis of clinical performance demonstrated that the test could differentiate between high-risk and low-risk patients, with high-risk being approximately six times more likely to have a rejection.
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Verici will assess the combination of its pre-transplant test, Clarava, in conjunction with its post-transplant test, Tutivia, which provides answers to whether the patient is experiencing a rejection event after the transplant.
The company has a further complementary test in clinical trials, Protega, which will be used to assess long-term damage. This means the company will provide an end-to-end testing platform with pre-, early post-, and late post-transplant tests.
It is anticipated that the technology will push organ donation. Any improvements in patient outcomes will encourage donors and create an increased focus on organ donation. Knowing that the organ will be used productively and efficiently will help families when deciding whether to donate.
As Verici looks to the future, they expect that RNA signature technology can be applied to other organ transplants. Further, early data has suggested that it specifically applies to autoimmune diseases. So long-term, RNA signature could be a very versatile platform.