Detecting kidney rejection via biomarker

LEE’S SUMMIT, Mo.—Eurofins Viracor, a diagnostics company focused on advancing diagnostic tests for transplant patients, has reported that the company has entered into a license agreement with the Cleveland Clinic for exclusive rights to an innovative urine biomarker test for detection of rejection in kidney transplant patients.

Finding out whether there is transplant rejection before damage can occur to the transplanted kidney is vital, and it is a major unmet need. Diagnosing clinical acute rejection (cAR) without a biopsy, and distinguishing cAR from other non-rejection causes of dysfunction, remains challenging for the transplant community.

Through years of basic and clinical research, Dr. Robert Fairchild from the Cleveland Clinic, and Dr. Roslyn Mannon from the University of Alabama, have identified a number of RNA molecules in urine that are highly accurate for the diagnosis of rejection, and elevated risk of rejection, in kidney transplant patients. Urine as a specimen type is a readily available, non-invasive, and convenient test for patients.

Fairchild and the Eurofins Viracor laboratory plan to work collaboratively to begin the critical process of sharing expertise and methods developed at Cleveland Clinic. The partnership will have a long-term goal of validating the novel, innovative diagnostic assay for use in patient testing.

The combined transplant diagnostics portfolio of the Eurofins Viracor laboratory, along with Transplant Genomics’ innovative testing for subclinical rejection, will help pave the way for Eurofins’ goal of improving graft and transplant outcomes, prolonging the life of a kidney, and addressing unmet needs in transplant patient care.

Eurofins Scientific first acquired Transplant Genomics in 2019, and in early 2020 Eurofins Viracor partnered with Transplant Genomics to expand non-invasive testing capabilities in settings outside of transplant centers. 

In 2020, Eurofins Viracor also announced a research collaboration with the Northwestern University Comprehensive Transplant Center. The collaboration is meant to further verify Transplant Genomics’ TruGraf test, which is a blood test intended to rule out silent rejection without the need for surveillance biopsies. The collaboration efforts extend a collaboration begun with Transplant Genomics over four years ago, and will help provide more clinical data for the TruGraf test.