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Transplant Genomics Kidney Transplant Test Gets Final Medicare Coverage Decision

NEW YORK — Transplant Genomics said today that its TruGraf Blood Gene Expression kidney transplant test qualifies for Medicare coverage beginning on Nov. 25.

TruGraf is a DNA microarray test that assesses differentially expressed genes in blood to rule out subclinical kidney transplant rejection in patients with stable renal function, providing an alternative to surveillance biopsies. 

Earlier this year, Molecular Diagnostic Services Program administrator Palmetto GBA issued a draft local coverage determination for TruGraf, with a number of other Medicare Administrative Contractors following suit. According to Mansfield, Massachusetts-based Transplant Genomics — which was acquired by Eurofins Scientific in June — the Centers for Medicare and Medicaid Services has now released the final version of the coverage policy issued by Palmetto.

"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," Transplant Genomics President Stan Rose said in a statement. "Working together with our sister Eurofins company [the post-transplant lab] Viracor, we have already begun discussions with transplant nephrologists around the country who are looking forward to incorporating TruGraf testing into their practice."