Medicare Issues Draft Local Coverage Determination (LCD) for Transplant Genomics’ TruGraf® Blood Test as Alternative to Surveillance Biopsies
MANSFIELD, Mass., March 29, 2019 — Transplant Genomics Inc. (TGI) announces that Palmetto GBA has released a draft local coverage determination (LCD) for TruGraf. TruGraf is the first and only non-invasive test validated to rule out subclinical “silent” rejection in kidney transplant patients with stable renal function, offering an alternative to surveillance biopsies.
“This marks an important milestone in making TruGraf available to kidney transplant patients,” said Dr. Stan Rose, Chief Executive Officer at TGI. “We conducted a very successful early access program involving 7 highly respected US transplant centers1 and are targeting a broad commercial launch of TruGraf later in 2019 following the completion of reimbursement discussions. The draft LCD release is particularly gratifying given all the hard work that has gone into developing TruGraf, and the promise this test holds for improving management of stable kidney transplant recipients, reducing the use of indiscriminate invasive procedures, and potentially improving long-term outcomes.”
The draft local coverage decision was issued following completion of the MolDx (Molecular Diagnostics) Technical Assessment process by Palmetto GBA. During the technical assessment process, subject matter experts and the MolDx team determine if an assay demonstrates clinical utility and fulfills the Centers for Medicare & Medicaid Services (CMS) ‘reasonable and necessary’ criteria.
There were over 20,000 kidney transplants in 2018 in the US. Our ability to personalize management of kidney transplant recipients has been limited by a lack of non-invasive and specific tools to assess for true stability of the transplant. “TruGraf provides clinicians with a non-invasive test that can confirm when things are going right, sparing up to 75% of their patients the need for an invasive protocol biopsy” stated Dr. John Friedewald, Medical Director of Kidney and Pancreas Transplantation at Northwestern University’s Comprehensive Transplant Center.
Last year TGI’s founding scientists published the results of an NIH-sponsored trial (“CTOT-08”)2 involving serial testing of more than 300 patients over 2 years. During the course of this study 25% of patients with stable renal function, who otherwise appeared perfectly fine, had at least one episode of biopsy-confirmed subclinical “silent” rejection. Until now, the only way to detect silent rejection has been through the indiscriminate use of surveillance biopsies which are logistically challenging, costly, painful and risk complications for patients. As described in today’s LCD, TruGraf is the first and only non-invasive test validated “as an alternative to surveillance biopsies in kidney transplant recipients greater than 90 days post transplant, in conjunction with standard clinical assessment.” Other tests have recently been approved for use in patients already suspected of severe “active” rejection; only TruGraf has been recommended for use in regular serial testing of patients with stable renal function, enabling early intervention before evidence of damage to the transplanted kidney.
The draft LCD can be found online here:
- Marsh et al. Application of TruGraf® v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients with Stable Renal Function. Transplant Proceedings, January 2019
- Friedewald et al. Development and clinical validity of a novel blood-based molecular biomarker for subclinical acute rejection following kidney transplantation. American Journal of Transplantation July 2018
Darren Lee, Transplant Genomics Inc., at 508-337-6200 or firstname.lastname@example.org
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 lab in Pleasanton, CA. www.transplantgenomics.com