MANSFIELD, Mass., Transplant Genomics, Inc. (“TGI”), a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by genomics, today announced that the Company’s TruGraf ® Blood Gene Expression Test qualifies for Medicare coverage effective November 25, 2019. The Centers for Medicare and Medicaid Services (CMS) released the final version of the coverage policy issued by Palmetto GBA, the Medicare administrator responsible for the MolDX technology assessment program that evaluated TruGraf.
"This is a major milestone for TGI. TruGraf is the first blood test that allows physicians to reassure patients with stable renal function following kidney transplants that their graft is not harboring silent rejection without the need for an invasive and costly surveillance biopsy. Approximately 25% of stable kidney transplant recipients harbor silent rejection, which previously could only be ruled out by performing surveillance biopsies on patients who appear to be perfectly fine" said Dr. Stan Rose, President, Transplant Genomics. "Working together with our sister Eurofins company Viracor, we have already begun discussions with transplant nephrologists around the country who are looking forward to incorporating TruGraf testing into their practice. “It’s been estimated that greater than 60% of US kidney transplant patients are covered by Medicare, meaning that most American kidney transplant recipients with stable renal function will be eligible to benefit from TruGraf testing,” added Rose.
Eurofins U.S. Clinical Diagnostics organization now 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, benefiting the lives of kidney donors, those with end stage renal disease awaiting transplant, and kidney transplant recipients.
Darren Lee, Vice President Transplant Marketing
Eurofins U.S. Clinical Diagnostics
508-337-6200 or DarrenLee@EurofinsUS.com
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. TGI was acquired by Eurofins in 2019.
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.