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