September 26, 2019
Eurofins Viracor, Inc. (“Viracor”) became aware today that CareDx has filed suit in the United States District Court for District of Delaware, alleging infringement of U.S. Patent No. 8,703,652 by three of Viracor’s tests: Viracor TRAC™ Kidney dd-cfDNA, Viracor TRAC™ Heart dd-cfDNA and Viracor TRAC™ Lung dd-cfDNA.
“Based upon our review of the suit, we believe our tests do not infringe the ‘652 patent. Moreover, we believe CareDx’s ‘652 patent to be invalid. As such, Viracor intends to vigorously defend against this lawsuit, and we do not anticipate this suit to impact our commercialization efforts. We exclusively licensed the intellectual property to perform these tests from the same institution from which CareDx licensed its intellectual property. We note that CareDx seems to be attempting to limit other laboratories from offering different cell-free DNA testing methodologies to help physicians confirm active organ rejection for transplant patients. This is evidenced by CareDx’s similar lawsuit against Natera, Inc. earlier this year, which also included the ‘652 patent and which Natera is defending in similar fashion,” said David Morgan, Senior Vice President, Eurofins U.S. Clinical Diagnostics.
“Given the increasing number of diagnostic tools in the clinical marketplace related to organ rejection, it is important to note this lawsuit does not involve the TruGraf ® Blood Gene Expression Test, which will be offered by Viracor’s sister company Transplant Genomics, Inc. (“TGI”) upon receipt of a final Local Coverage Determination from Centers for Medicare & Medicaid Services via Palmetto GBA’s Molecular Diagnostic Services (MolDX) Program. While cell-free DNA tests provide important information to physicians seeking to rule out active rejection in kidney transplant patients already showing signs of renal dysfunction, TruGraf ® will be the first and so far only blood test that allows physicians to reassure patients with stable renal function that their graft is not harboring silent rejection without the need for an invasive and costly surveillance biopsy. Silent rejection occurs in about 30% of kidney transplant patients and if untreated can progress to active rejection,” added Morgan.
Through Viracor, TGI and Eurofins VRL, Inc., Eurofins U.S. Clinical Diagnostics offers an expansive suite of testing services covering pre-transplant through post-transplant patient monitoring. We provide the country’s most comprehensive portfolio of transplant diagnostic tests.
About Viracor Eurofins
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor Eurofins is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies 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 (EUFI.PA), a global leader in bio-analytical testing, and one of the world leaders in genomic services. For more information, please visit https://www.eurofins.com/ and https://www.viracor-eurofins.com/ .
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.