LUXEMBOURG--(BUSINESS WIRE)--Regulatory News:
Eurofins Scientific (EUFI.PA), a global scientific leader in bioanalytical testing, announces that it has successfully closed the acquisition of Transplant Genomics Inc. (“TGI”), a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by genomics.
TGI’s innovative non-invasive tests for the management of patients with silent inflammation and rejection following kidney transplants will strengthen and complement Eurofins’ industry leading global Transplant Diagnostics offering, which includes VRL, Inc., the largest pre-transplant laboratory in the U.S. and Viracor, Inc., the largest specialty post-transplant clinical laboratory in the U.S. Viracor currently serves approximately 70% of all transplant programs in the U.S., focusing on post-transplant infectious disease and immune status monitoring services. Eurofins’ Transplant Diagnostics capabilities and market footprint provide an ideal platform in which to launch TGI’s highly anticipated TruGraf blood gene expression test, capable of reliably ruling out “silent” subclinical kidney rejection in kidney transplant patients with stable kidney function. TGI has recently received a draft Local Coverage Determination (LCD) decision from Centers for Medicare & Medicaid Services (CMS) via Palmetto GBA’s Molecular Diagnostic Services (MolDX) Program, supporting the upcoming launch of TruGraf.
Kidney transplantation is universally recognized as the treatment of choice for patients with End Stage Renal Disease. Clinical outcomes of kidney transplantation have improved steadily for decades, although rejection of the transplanted organ remains one of the key challenges to long-term survival. The current standard method for ruling out the presence of subclinical allograft rejection in patients with stable renal function consists of performing a “surveillance” organ biopsy, which is an invasive technique that suffers from high cost, sampling error, subjective analysis, logistical challenges for patients and transplant centers, and potential complications. Moreover, ~80% of surveillance biopsies are negative (i.e. normal) and as a result, these patients are unnecessarily subjected to the risks of a biopsy. As a solution to this challenge, TGI worked with leading researchers at Northwestern University’s Comprehensive Transplant Center and The Scripps Research Institute to develop TruGraf. TruGraf is the first blood test that allows physicians to reassure patients with stable renal function following kidney transplants that their graft is not harbouring silent rejection without the need for an invasive and costly surveillance biopsy. This technology is also expected to be useful in other transplanted organ types for both subclinical and clinical rejection
Comment from Dr. Gilles Martin, Eurofins CEO: “We are very pleased to welcome Transplant Genomics and its team of outstanding scientists to the Eurofins Group. This acquisition significantly reinforces the large existing range of innovative tests our Group laboratories offers to transplant hospitals, and practitioners in the United States and strengthens Eurofins leadership position in the transplant testing market and our ability to deploy the latest scientific advances to benefit patients.”
Comment from Dr. Stan Rose, Transplant Genomics CEO: “Transplant Genomics is very excited to become part of Eurofins, the global leader in Transplant Diagnostics. Joining the Eurofins Group will enable us to launch our TruGraf subclinical kidney rejection assay in the best possible conditions to enable us to improve organ transplant outcomes for as many patients as possible.”
Comment from Dr. Michael Abecassis, Transplant Genomics co-Founder and Founding Director of the Comprehensive Transplant Center at Northwestern University’s Feinberg School of Medicine: “When Dan Salomon and I co-Founded TGI with Stan Rose, our primary and only objective was to ensure that our patients would someday benefit from our biomarker discovery research to improve their transplant outcomes. TGI has been the perfect initial vehicle to address this objective by monetizing the regulatory requirements to commercialize our discovery bringing our research closer to the bedside. By acquiring TGI, Eurofins will not only fully deliver on our initial objective, but will also help us deliver on our promise to Dan, who was taken from us prematurely 2 years ago, to secure his legacy in this space. We look forward to working closely with our new partners at Eurofins as we continue to discover, develop, and validate innovative, non-invasive biomarker approaches that provide actionable information to improve transplant outcomes across organs, establishing new standards in the monitoring and management of our transplant patients.”
Notes for the editor:
About Transplant Genomics, Inc.
Transplant Genomics Inc. (“TGI”) is a molecular diagnostics company committed to improving organ transplant outcomes, 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 Pleasanton, CA.
Eurofins – a global leader in bio-analysis
Eurofins Scientific through its subsidiaries (hereinafter sometimes “Eurofins” or “the Group”) 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 for 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 objective is to provide its customers with high-quality services, accurate results on time and 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 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).
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.