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.