Blood-based biomarker found to be viable alternative to surveillance biopsy for stable kidney transplant patients
MANSFIELD, Mass., May 28, 2020 – Transplant Genomics Inc. (TGI), the leader in bringing personalized diagnostics to transplant patients worldwide, announces that TGI Clinical Advisor, Dr. John Friedewald of Northwestern University will receive a top honor at the American Transplant Congress (ATC2020). On June 1, Dr. Friedewald will receive The American Journal of Transplantation (AJT) 2020 Outstanding Article Award in Translational Science for his groundbreaking scientific publication. “Development and clinical validity of a novel blood-based molecular biomarker for sub-clinical acute rejection following kidney transplant” was published in the January 2019 edition of AJT.
The paper, by Dr. Friedewald and his colleagues, reports on the development and validation of blood-based biomarkers to rule out “silent” subclinical acute rejection (subAR) in stable kidney transplant patients. The NIH-funded, multi-center Clinical Trials in Organ Transplantation (CTOT08) study, which informed the paper, definitively establishes that stable kidney transplant patients with biopsy-proven subAR have worse outcomes than those who do not have subAR. The study also shows that non-invasive blood tests are just as effective at ruling out subAR as invasive surveillance biopsies and are a viable, less-risky alternative to serially monitor stable kidney patients.
Out of the 307 stable patients studied over 24 months in CTOT08, ~25% were shown to have subAR, a condition also shown to negatively impact graft outcomes. Prior to this study, the only way to monitor patients for subAR was to perform serial invasive surveillance biopsies. Considering ~75% of patients were found to be negative for subAR, Friedewald says these biopsies can expose patients to unnecessary risk.
The findings are particularly relevant today, as doctors look for new ways to protect transplant patients from COVID-19. Instead of bringing stable patients into the hospital for a biopsy– where risk to COVID-19 exposure can be high and resources can be scarce – this non-invasive test can be done regularly by collecting blood samples at home using a mobile phlebotomist. TGI holds the U.S. patent on the use of blood gene expression profiling by various technical approaches to rule out subAR. The CLIA-certified laboratory began offering the first commercial test using this approach, TruGraf® , in 2019. It was developed and validated as the first and only blood test to non-invasively rule out silent rejection in stable kidney transplant recipients covered by The Centers for Medicare and Medicaid Services (CMS). TruGraf® is indicated for use in renal transplant patients who are at least 18 years old and at least 90 days post-transplant with stable serum creatinine values.
Blood samples for TruGraf® testing can be collected through TGI’s newly launched Labs@Home program. For information on ordering tests and arranging remote sample collection, physicians may contact TGI at 1-844-TruGraf. Ordering and general information is also available on our website at www.trugraf.com.
Sloane Heller Communications
About Transplant Genomics, Inc.
Transplant Genomics, Inc. (“TGI”) is a molecular diagnostics company bringing personalized diagnostics to transplant patients worldwide, with an initial focus on kidney transplant recipients. Working with the transplant community, TGI is commercializing a suite of tests enabling diagnosis and prediction of transplant recipient immune status. Test results will support clinicians with information to optimize immune-suppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA laboratory in Fremont, CA.
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