Mar 8, 2019 | Research |
Transplant Genomics Inc, Mansfield, Mass, a molecular diagnostics company committed to improving organ transplant outcomes, has announced the publication of two studies of the company’s gene-expression assay, TruGraf, in applications to detect biomarkers for managing kidney transplant recipients and as a molecular diagnostic test in clinical practice.1,2
The reports describe a comprehensive series of retrospective and prospective studies conducted at seven transplant centers. Clinical utility of the blood-based TruGraf assay was demonstrated to rule out silent (subclinical) rejection during the first few years after kidney transplantation, with an overall negative predictive value >90%, for the first time offering a noninvasive alternative to ‘surveillance’ biopsies.
Both retrospective and prospective studies of decision impact revealed that TruGraf testing supported clinicians’ decisions regarding patient management in approximately 87% of cases.
Silent rejection is histology-proven rejection that occurs 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 after transplantation. But until now, the phenomenon could only be detected by performing an invasive ‘surveillance’ biopsy—a significant imposition on a patient who appears to be perfectly fine. Such biopsies are painful, costly, carry the risk of complications, and are negative 75% of the time.
“These studies provided clinical validation of TruGraf performance across seven different transplant programs, while also demonstrating the clinical utility of TruGraf as the first noninvasive alternative to surveillance biopsies for ruling out silent rejection,” says Stan Rose, PhD, CEO of Transplant Genomics. “Clinicians finally have a noninvasive tool to help them better manage kidney transplant recipients with stable renal function, before there is suspicion of rejection or evidence of graft damage.”
For further information, visit Transplant Genomics.
References
- First MR, Peddi VR, Mannon R, et al. Investigator assessment of the utility of the TruGraf molecular diagnostic test in clinical practice. Transplant Proc. Epub before print, December 11, 2018; doi: 10.1016/j.transproceed.2018.10.024.
- Marsh CL, Kurian, SM, Rice JC, et al. Application of TruGraf v1: a novel molecular biomarker for managing kidney transplant recipients with stable renal function. Transplant Proc. Epub before print, January 26, 2019; doi: 10.1016/j.transproceed.2019.01.054.
Rate:
