Mansfield, MA, October 24, 2017 —
Transplant Genomics Inc. (TGI), a molecular diagnostics company committed to improving organ transplant outcomes, announces a publication titled “Analytical and Clinical Validation of a Molecular Diagnostic Signature in Kidney Transplant Recipients” in the Journal of Transplantation Technologies & Research. This report describes a comprehensive series of studies conducted in TGI’s CLIA laboratory to demonstrate clinical validity and verify the analytical performance of the blood-based TruGraf™ gene expression assay used to assess the adequacy of immunosuppression after kidney transplantation.
Lead author, Dr. M. Roy First, Chief Medical Officer at TGI stated, “This report for the first time demonstrates the validity and potential utility of a simple blood test as a non-invasive alternative to surveillance biopsies for confirming immune quiescence in kidney transplant recipients with stable renal function. With both analytical and clinical validity firmly established, we have embarked on multiple studies to evaluate clinical utility for a test that has the potential to represent the first major advance in decades in kidney transplant monitoring and provide a first step towards improving long term outcomes through personalized immunosuppression.”
- Analytical performance is not affected across a broad range of input RNA concentration, environmental factors or interfering substances.
- TruGraf exhibits an 88% PPV for detecting patients who are truly TX (ie., immune quiescent) when applied to the target population specified by our initial indication for use
- In the external cohort evaluated in this study, approximately two-thirds of protocol biopsies could have been spared for patients who would not have benefited from these invasive procedures
The paper describes analytical performance studies which characterize the stability of RNA in blood during collection and shipment, analytical sensitivity as applied to input RNA concentration, analytical specificity, and assay performance studies including intra-assay and inter-assay reproducibility. Clinical validity is established by comparing TruGraf test results with histological phenotyping of biopsy tissue collected from renal grafts at the same time as blood samples were drawn.
The primary indication for use of TruGraf is to assess adequacy of immunosuppression in kidney transplant recipients with stable renal function as an alternative to performing invasive surveillance “protocol” biopsies, or simply waiting for clinical signs of kidney damage to present. In contrast to other tests that may help sort out the nature of problems already suggested by traditional markers of rejection such as elevated serum creatinine or DSA, TruGraf is intended to be used while patients still appear to be stable, a period during which 20-25% are known to be silently rejecting (experiencing “sub-clinical acute rejection”, or subAR).
A copy of the study can be obtained from the Transplant Genomics’ website, or through the following link to the Journal of Transplantation Technologies & Research on-line publication: https://www.omicsonline.org/ArchiveJTTR/articleinpress-transplantation-technologies-research-open-access.php)
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