Outstanding Innovation in Therapeutics & Diagnostics:
Robert Fairchild, PhD


Robert Fairchild, PhD, joined Cleveland Clinic in 1990 after graduate education at Miami University and the University of Missouri and post-doctoral fellowships with the University of Colorado’s School of Medicine and the National Jewish Center for Immunology and Respiratory Medicine. Recruited to Cleveland Clinic to launch a transplant immunology research program, Dr. Fairchild brought with him extensive knowledge of chemokine production, leukocyte infiltration and their roles in immune response. Thirty years later, Dr. Fairchild leads a lab of 11 team members within the Lerner Research Institute, studying the role of immuno-inflammatory processes in acute or subacute T-cell and antibody-mediated rejection of heart and kidney allografts. Funded by the National Institute of Allergy and Infectious Diseases, his lab is a molecular diagnostics core of the Clinical Trials in Organ Transplantation consortium.

Dr. Fairchild’s longtime focus has been the development of non-invasive methods to monitor kidney transplant patients by identifying markers of rejection through interrogation of RNA isolated from patient urine. For years, his team worked to identify chemokine and chemokine receptor gene expression that indicated ongoing acute rejection using polymerase chain reaction. This practice advanced quickly in 2015 when Dr. Fairchild and his colleague Roslyn Mannon, MD, from the University of Nebraska Medical Center, became aware of a multiplex platform to probe and monitor the expression of about 800 different genes. Using the platform, his lab compared urine samples of healthy kidney patients to the urine of those with biopsy-confirmed acute rejection. Between the populations, they found marked differences in the expression of specific transcripts found in urine.

Although the transplant rejection biomarker space is crowded, many transplantation market participants are currently using a three- or four-gene signature for graft rejection diagnosis. In contrast, Drs. Fairchild and Mannon’s non-invasive assay uses about 20 genes that can accurately distinguish graft injury from non-injury. Importantly, the assay has the potential to distinguish between a true T-cell mediated kidney graft rejection event and a BK (polyomavirus) virus infection, which is common post-transplant.

In December 2020, the platform was licensed to Eurofins-Viracor, a diagnostic laboratory company specializing in infectious disease, immunology and allergy testing for immunocompromised and critical patients. Dr. Fairchild is actively involved in verifying the assay with Eurofins-Viracor, as well as advancing and diversifying the diagnostic ability of the test to detect antibody-mediated rejection, polyomavirus infection and interstitial fibrosis/tubular atrophy. Its ability to overrule current biopsy-based diagnostics represents an important advancement for kidney transplant patients worldwide. 

Congratulations to Dr. Fairchild and his co-inventors on the development and subsequent 2020 license of their platform.

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