Post-Transplant Complications Pose Risks
for Allograft Function In the United

In the United States alone, nearly 40,000 organ transplants are performed annually, with kidney, liver, heart, and lung being the most common.
Living donor and deceased donor organ transplants have substantially improved the quality of life for hundreds of thousands of patients.
However, despite continuous advancements in surgical and medical practices, acute organ rejection and long-term allograft survival remain significant post-transplant complications. Acute rejection, including subclinical acute rejection, can negatively impact patient quality of life and lead to chronic rejection — minimizing allograft survival and requiring re-transplantation or other interventions.
Non-invasive Genomic Monitoring Can Improve Transplant Outcomes
Since 2014, Transplant Genomics, Inc. has been committed to improving organ transplant outcomes through non-invasive molecular diagnostics that detect early signs of allograft injury, differentiate among actionable causes, and optimize therapy.
The standard protocols for post-transplant monitoring rely on late-trailing indicators of graft function or painful, expensive, and invasive surveillance biopsies. These tests may not indicate imminent rejection until the allograft is significantly damaged, leaving clinicians and patients fewer options to improve organ health before more severe complications occur.
Transplant Genomic’s extensive development pipeline includes non-invasive diagnostic and predictive tests for kidney and liver graft dysfunction, the use of multiple sample types and technology platforms, companion diagnostics for immunosuppressants, and immune status tests.
of patients
show subclinical
acute rejection
of patients receive a
surveillance biopsy
in the first year
of patients who have surveillance biopsies show normal histology and the vast majority could have been spared an invasive procedure if tested with TruGraf®

TruGraf® is the first and only non-invasive test covered by CMS as an alternative to surveillance biopsies to rule out silent subclinical acute rejection in transplant patients with stable graft function.

Despite improvement in short-term outcomes, long-term outcomes for kidney transplant recipients remain suboptimal. Immunological rejection is a leading cause of graft failure and recent research points to undetected “silent” subclinical acute rejection (subAR) in patients with stable renal function as a key component of this problem.

Traditionally the diagnosis of silent subclinical rejection has required a surveillance biopsy on a stable patient, but it’s widely acknowledged that a non-invasive method would offer significant advantages especially in terms of patient safety. TruGraf®, a clinically-validated, blood-based gene expression assay, is the first and only non-invasive test designed and validated to rule out silent rejection, offering the potential to limit use of surveillance biopsies to patients most likely to benefit from them.

Learn more about TruGraf

With the outbreak of COVID-19, transplant programs are minimizing office visits, both to ensure patient health and safety, as well as reduce the burden on staff so they may focus their care on patients who are most in need. To help physicians continue to provide state-of-the-art care for their patients without requiring them to visit the transplant center, we offer a comprehensive catalog of tests – all of which can be run from samples collected remotely – via our mobile phlebotomy service, Labs@HOME.

The Labs@HOME service allows physicians to order and customize a limited menu of infectious disease and transplant-related testing. The specimen collection is performed safely and securely by a qualified phlebotomist who will work with the patient to schedule an appointment at the patient’s residence. This ensures routine transplant testing is available to high risk patients in their homes—eliminating the need to visit the hospital or transplant center when it is not critically necessary.

Learn more about Labs@HOME
The TRULO clinical study includes 2,000 transplant patients from up to 50 transplant centers, incorporating both TruGraf® patient monitoring and TRAC™ dd-cfDNA measurements. This study is unique in that it focuses on patients that are more remote from their transplant and will correlate TruGraf® and TRAC™ monitoring with long-term outcomes. With TruGraf® and TRAC™ tested simultaneously, this study will offer the first head-to-head comparison of gene expression profiling and cfDNA, while simultaneously identifying their complementary use in different patient cohorts (stable graft function vs. renal dysfunction) and synergies for detecting TCMR.
Learn more about TRULO

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