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Eurofins Transplant Diagnostics Group Receives New York State CLEP Approval for Novel Rejection Biomarker Assays
[April 27, 2021]

Eurofins Transplant Diagnostics Group Receives New York State CLEP Approval for Novel Rejection Biomarker Assays


LEE'S SUMMIT, Mo. and FRAMINGHAM, Mass., April 27, 2021 /PRNewswire/ -- Eurofins Viracor, one of the largest and most recognized infectious diseases testing laboratories in the United States, and Transplant Genomics, the trusted global partner in precision biomarkers for the transplant community innovating to improve patient outcomes, announce that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Viracor TRAC™ (Transplant Allograft Rejection Check) donor-derived cell-free DNA test and TruGraf® blood gene expression test, both of which help healthcare providers assess rejection status in kidney transplant recipients.

Clinical laboratories conducting clinical or forensic testing on specimens originating in New York State, regardless of location, must hold a New York State Department of Health clinical laboratory permit. The New York State Department of Health established CLEP to ensure test accuracy and reliability for the state's residents through strict evaluation standards. With CLEP approval, Eurofins' TRAC and TruGraf tests are now available to patients in New York and in all 50 states.

Dr. Enver Akalin, MD, FAST, FASN, Professor of Medicine and Surgery at the Albert Einstein College of Medicine and Medical Director of the Kidney and Pancreas Transplant Program at Montefiore Medical Center commented, "This is excellent news for kidney transplant patients in New York."

Viracor TRAC is a non-invasive, proprietary, donor derived cell-free DNA (dd-cfDNA) method for early detection of rejection in renal transplant patients. The current gold standard method of rejection diagnosis and surveillance is organ biopsy, an invasive technique that is costly and may present further complications for the patient. Through its work with the American Medical Association/CPT®, Eurofins Viracor has secured a Proprietary Laboratory Analyses (PLA) code for Viracor TRAC.

The TruGraf blood gene expression test offers clinicians the earliest possible opportunity to rule out "silent" subclinical acute rejection in kidney transplant recipients with stable renal function. Following a simple, non-invasive blood draw, TruGraf detects an early change in the patient's gene expression as the immune system actives prior to the clinically-observable signs of acute rejection. This early assessment of impending rejection offers clinicians the widest possible opportunity to intervene and improve kidney transplant outcomes.

Eurofins Viracor and Transplant Genomics are both part of the Eurofins Transplant Diagnostics group, the industry innovator in comprehensive transplant testing that informs, monitors, and leads to predictive analysis for patients and providers seeking personalized insights that can answer life nd organ saving transplant questions at a time when accuracy and speed matter most.



For more information on TruGraf, please visit www.trugraf.com. For more information on TRAC, please visit www.eurofins-viracor.com.

MEDIA CONTACT:
Sally Maysent
Eurofins Viracor
e) sallymaysent@eurofins-viracor.com
p) 816-912-9527


Branden Morris
Transplant Genomics
e) brandenmorris@eurofins-tgi.com
p) 510-745-4707

About Eurofins Viracor

With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Eurofins Viracor is committed to helping medical professionals, transplant teams and reference laboratories get results faster, when it matters most. Viracor is passionate about delivering value to its clients by providing timely, actionable information, never losing sight of the connection between the testing it performs and the patients it ultimately serves. Viracor is a 100 percent subsidiary of Eurofins Scientific, the global leader in bio-analytical testing, and one of the world leaders in genomic services.

Learn more about https://www. eurofins-viracor.com.

About Transplant Genomics

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 gene expression 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.transplantgenomics.com.

About Eurofins Scientific

Eurofins Scientific (hereinafter sometimes "Eurofins" or "the Group"), through its subsidiaries, believes it is a scientific leader in food, environment, 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 supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing. With about 45,000 staff in more than 800 laboratories across 47 countries, Eurofins offers a portfolio of over 200,000 analytical methods for evaluating the safety, identity, composition, authenticity, origin, and purity of biological substances and products, as well as for innovative clinical diagnostic. The Group's objective is to provide its customers with high-quality services, accurate results on time, and expert advice from highly qualified staff.

Eurofins is committed to pursuing its dynamic growth strategy by expanding its technology portfolio and its geographic reach. Through R & D and acquisitions, the Group draws on the latest developments in biotechnology and analytical chemistry to offer its clients unique analytical solutions and the most comprehensive range of testing methods.

As one of the most innovative and quality-oriented international players in its industry, Eurofins is ideally positioned to support its clients' increasingly stringent quality and safety standards and the expanding demands of regulatory authorities around the world.

The shares of Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).

Learn more about Eurofins at http://www.eurofins.com.

Important disclaimer:

This press release contains forward-looking statements and estimates that involve risks and uncertainties. The forward-looking statements and estimates contained herein represent the judgment of Eurofins Scientific's management as of the date of this release. These forward-looking statements are not guarantees for future performance, and the forward-looking events discussed in this release may not occur. Eurofins Scientific disclaims any intent or obligation to update any of these forward-looking statements and estimates. All statements and estimates are made based on the information available to the Company's management as of the date of publication, but no guarantee can be made as to their validity.

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SOURCE Eurofins Transplant Diagnostics


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