Mansfield, MA, May 21, 2020 —
MANSFIELD, MA., Transplant Genomics, Inc. (“TGI”), Following the launch in April 2020 of Labs@Home in response to the COVID-19 pandemic began impacting transplant patient care and the world, Transplant Genomics, Inc. (“TGI”), announce today the successful growth of TruGraf® driven by adoption of Labs@Home. TruGraf, the only blood test approved by CMS for surveillance to rule out “silent” subclinical acute rejection (subAR) in kidney transplant recipients with stable graft function, has been recognized as crucial to reducing risk in outpatient management after a kidney transplant during COVID-19 in a recent published article from Yale University.
During the COVID-19 pandemic, typical protocols for management of kidney transplant recipients have been difficult to maintain as immunocompromised patients have been urged to stay at home and avoid visiting clinics for routine blood draws or surveillance biopsies. At the same time, clinicians understand that lack of adequate surveillance poses an even greater risk to their patients’ health. Published data informs us that while ~25% of patients undergoing a surveillance biopsy will show signs of rejection roughly three times as many, i.e. ~75%, will have a healthy kidney, which means that with the benefit of hindsight, the invasive tissue biopsy was ultimately unnecessary. With the presence of COVID-19, these risks are further inflated, creating significant unnecessary risks for otherwise healthy patients, making them the highest risk-benefit category of transplant recipients. For these patients with stable graft function, TruGraf, a peripheral blood gene expression test, provides a liquid biopsy alternative that can reliably rule out whether there is “silent” subclinical acute rejection. Labs@Home enables the necessary blood samples to be collected at home, enabling patients to avoid taking on the added risk of a clinic visit, and minimizing the patient load at hospitals where resources are devoted to COVID-19 care.
In one recent published article from Yale School of Medicine, Drs. Shana E. Gleeson, Richard N. Formica, and Ethan P. Marin highlighted this problem accurately, reminding physicians and patients alike the critical benefit and differences in context-of-use between TruGraf and donor-derived cell-free DNA (dd-cfDNA) that “Performance of for-cause biopsies presents another exposure risk, and during this pandemic, the risk-benefit ratio must now incorporate potential exposure to SARS-CoV-2 in the health care facility. As an alternative, practitioners may consider using noninvasive measures of transplant rejection, such as donor-derived cell-free DNA (which may be used in place of for-cause biopsy) or peripheral blood gene expression tests (which may substitute for protocol biopsies).”
Labs@Home is an in-home blood draw service to aid in specimen collection for routine labs and speciality labs directly from a patient’s home. Through our partners at Viracor, clinicians can order and customize remote sample collection to test for a number of infectious diseases, including COVID-19. As part of Eurofins, TGI is actively working to further improve the convenience and quality of service offered to transplant patients, with more announcements expected soon.
For information on ordering tests and arranging remote sample collection, physicians may contact TGI about TruGraf tests by calling 1-844-TruGraf. Ordering and general information is also available on our websites at www.trugraf.com.
Eurofins U.S. Clinical Diagnostics
860 817 0151 or xiomaraortiz@EurofinsUS.com
About Transplant Genomics
Transplant Genomics (“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 Fremont, 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.
SOURCE Eurofins Transplant Genomics