Transplant Genomics, Inc. ("TGI"), a molecular diagnostics company committed to improving organ transplant outcomes with non-invasive serial monitoring guided by genomics, today received notice that the Molecular Diagnostics Services (MolDX) Program developed by Palmetto GBA has set TruGraf reimbursement at $2,840.75, per test performed.
Based on today's announcement, TruGraf will be reimbursed for kidney transplant patients covered by Medicare across the United States starting November 25, 2019, the effective date of the local coverage determination. More than 60% of U.S. Kidney transplant recipients are covered by Medicare.
TruGraf is the first and only non-invasive test validated and reimbursed for ruling out the presence of "silent" sub-clinical acute rejection in kidney transplant patients – the vast majority of whom have stable renal function at any given time. Approximately 25% of stable kidney transplant recipients harbor silent rejection, which previously could only be ruled out by performing invasive, costly and risky surveillance biopsies. TruGraf now provides a non-invasive alternative to surveillance biopsy for improved patient care.
Medicare reimbursement for TruGraf follows a rigorous technical assessment by the MolDX Program. Evidence in support of the TruGraf test included a clinical trial in 7 leading transplant centers. The TruGraf test is based on technology covered in US Patent No. 10,443,100, entitled "Gene expression profiles associated with sub-clinical kidney transplant rejection," which issued on October 15, 2019 and is licensed exclusively to TGI.
There are approximately 220,000 transplant recipients living with a functioning kidney in the US, and approximately 19,000 to 21,000 new kidney transplants being performed annually, growing at about 4.3% per year. "Based upon our research and knowledge of transplant programs, we estimate that more than 40% of kidney transplant centers in the U.S. conduct surveillance or protocol biopsies. Given the significantly lower complexity of a blood draw as compared to a kidney biopsy, transplant programs that do not currently conduct surveillance or protocol biopsies due to logistics or other complicating factors could become candidates for TruGraf testing to aid their patient management as well," stated Dr. Stan Rose, President & CEO of Transplant Genomics.
While there are no available non-invasive tests that directly compare to TruGraf for ruling out sub-clinical acute kidney rejection, there are tests that assess clinical suspicion of rejection ("active rejection"). We are encouraged that publicly available information would indicate that approximately 3% of living kidney transplant patients are benefitting from these recently introduced diagnostics associated with active rejection within the first two years of being available. We believe that the compelling data from our dozen early adoption partners that contributed to MolDX's local coverage decision supporting TruGraf, coupled with data from our ongoing studies at leading research and academic institutions, will help drive similar or higher adoption across the US and other international transplant programs across the world.
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.
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