Novel Biomarker-Based Assay Confirms Immune Quiescence in Liver Transplant Patients
MANSFIELD, MA — Transplant Genomics, Inc. (“TGI”) a member of Eurofins Transplant Diagnostics, is excited to introduce TruGraf Liver, the only non-invasive blood-based test to assist in lowering immunosuppression in liver transplant patients, at The Liver Meeting Digital Experience (“The Liver Meeting”). The Liver Meeting is the annual meeting of the American Association for the Study of Liver Diseases, being held online November 13-16, 2020. In continuation of Eurofins Transplant’s commitment to improving organ transplant outcomes worldwide, TruGraf Liver follows TruGraf®, the only non-invasive kidney rejection test reimbursed by CMS for the surveillance of “silent” sub-clinical acute rejection in patients with stable renal function.
Immunosuppression is essential to prevent rejection following liver transplantation. However, due to the significant complications associated with the use of immunosuppression, clinicians routinely minimize immunosuppression in liver transplant recipients in an effort to address these complications. TruGraf Liver is the first and only blood-based test that offers biomarker guidance to aid physicians in minimizing immunosuppression in transplant recipients. Until now, immunosuppression minimization has largely been a “trial and error” process, with clinicians relying only on laboratory and clinical indicators of rejection, graft injury, and failure resulting from the effects of immune activation. TruGraf Liver can help clinicians confirm immune quiescence prior to, as well as following, immunosuppression reduction in patients with stable graft function, minimizing the risk of overt graft injury due to rejection.
Josh Levitsky, MD, MS (Professor of Medicine and Surgery in the Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois) detailed the development of TruGraf Liver in his April 2020 article in the American Journal of Transplantation (https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.15953). This study is based on findings from an NIH-funded, multi-center longitudinal study (CTOT-14: NCT01672164) that has set the stage for the use of non-invasive biomarkers for serial monitoring of liver transplant recipients. He will present his study at The Liver Meeting on Sunday, November 15 at 1:00pm ET, in a satellite symposium titled “Biomarkers in Liver Transplantation: The Next Frontier.”
Transplant Genomics is currently selecting liver transplant centers for the TruGraf Liver Early Access Program, and is preparing documentation for submission to the Molecular Diagnostics Services (MolDX) program to determine reimbursement coverage from the Centers for Medicare and Medicaid Services. The Early Access Program will be followed by the TRULI (TruGraf Liver) Registry Study, which is expected to involve more than 30 liver transplant centers and enroll up to 1,000 patients.
Members of the American Association for the Study of Liver Diseases may register for The Liver Meeting 2020 to see Dr. Levitsky’s presentation at https://www.aasld.org/node/2046.
Hepatologists and other liver transplant care professionals may contact Transplant Genomics to learn more about TruGraf Liver at (844) 878-4723 or at email@example.com.
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Transplant Genomics, Inc.
About Transplant Genomics, Inc.
Transplant Genomics, Inc. (“TGI”) is a personalized diagnostics company committed to improving organ transplant outcomes worldwide through innovative tests that detect early signs of graft injury, differentiate among actionable causes, and enable the optimization of therapy. Working alongside the transplant community and within the Eurofins family, TGI is commercializing a suite of tests enabling diagnoses and prediction of transplant recipient immune status. Our flagship product is TruGraf, the only blood test approved by CMS for surveillance and to rule out “silent” subclinical acute rejection in kidney transplant recipients with stable graft function. Test services are offered through TGI’s CLIA laboratory in Fremont, CA. TGI was acquired by Eurofins Scientific in 2019.
Learn more about Transplant Genomics at http://www.trugraf.com.
About Eurofins Scientific
Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 50,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide its customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.
As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).
Learn more about Eurofins at https://www.eurofins.com.