Multi-Center Studies Demonstrate Clinical Utility of TruGraf as First Blood Test Able to Rule Out Silent Rejection in Stable Kidney Transplant Recipients

Tuesday, February 26, 2019 Clinical Trials News
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Non-Invasive Alternative to Surveillance Biopsy

MANSFIELD, Mass., Feb. 26, 2019 /PRNewswire/ -- Transplant Genomics Inc. (TGI), a molecular diagnostics company committed

to improving organ transplant outcomes, announces two publications in the journal Transplantation Proceedings:

  • Application of TruGraf® v1: A Novel Molecular Biomarker for Managing Kidney Transplant Recipients with Stable Renal Function
  • Investigator Assessment of the Utility of the TruGraf Molecular Diagnostic Test in Clinical Practice

These reports describe a comprehensive series of retrospective and prospective studies conducted in seven transplant centers. Clinical utility of the blood-based TruGraf™ gene expression assay was demonstrated to rule out silent (sub-clinical) rejection during the first few years after kidney transplantation with an overall NPV >90%, for the first time offering a non-invasive alternative to "surveillance" biopsies. Both retrospective and prospective studies of decision impact revealed that TruGraf testing supported clinician's decisions regarding patient management in approximately 87% of cases.

Silent rejection is histology proven rejection in patients with stable renal function and no outward signs of rejection. Silent rejection has been reported in approximately 25% of patients in the first few years post-transplant, but until now could only be detected by performing an invasive biopsy on a patient who appears to be perfectly fine. These "surveillance" biopsies are painful, costly, put patients at risk of complications, and turn out negative 75% of the time.

TGI's CEO Dr. Stan Rose stated, "These studies provided clinical validation of TruGraf performance across seven different transplant programs, while also demonstrating the clinical utility of TruGraf as the first non-invasive alternative to surveillance biopsies for ruling out silent rejection. Clinicians finally have a non-invasive tool to help them better manage kidney transplant recipients with stable renal function, before there is suspicion of rejection or evidence of graft damage."

A copy of these studies can be obtained from the Transplant Genomics' website, or through the following links to the journal Transplantation Proceedings:

  • https://www.sciencedirect.com/science/article/pii/S0041134518309813
  • https://www.sciencedirect.com/science/article/pii/S0041134518312697

MEDIA CONTACTS: Darren Lee, Transplant Genomics Inc., at 508-337-6200 or dlee@transplantgenomics.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 lab in Pleasanton, CA. www.transplantgenomics.com

Cision View original content:http://www.prnewswire.com/news-releases/multi-center-studies-demonstrate-clinical-utility-of-trugraf-as-first-blood-test-able-to-rule-out-silent-rejection-in-stable-kidney-transplant-recipients-300802268.html

SOURCE Transplant Genomics Inc.



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