The TruGraf^® test is intended for use in kidney transplant recipients with stable renal function as an alternative to surveillance biopsies to rule out “silent” subclinical rejection. It is the only test reimbursed as an alternative to a surveillance biopsy and the only test clinically validated with histologically confirmed samples to rule out subclinical rejection. TruGraf has a proven clinical performance demonstrating greater than 91% Negative Predictive value for ruling out subAR.

It is a minimally invasive blood-based test that by measure RNA gene expression in a patients sample, can determine if a patient is adequately immunosuppressed, ruling out subclinical acute rejection.

Unlike tests that confirm rejection or active rejection in patient with elevated serum creatinine, damage has already occurred to the transplanted kidney. TruGraf^® is used on patient with stable, renal function, before graft damage occurs.

TruGraf^® results inform a clinician if a patient with stable renal function (normal serum creatinine results) is adequately immunosuppressed (classified as TX for Transplant eXcellence) or inadequately immunosuppressed (classified as Not-TX). Considered in the context of the other clinical information available, a TruGraf^® result may be critical in supporting a physician decision regarding:

• As an alternative or complement to surveillance biopsies to rule-out presence of subclinical rejection
• Serially monitoring patients with any desired frequency, 24/7/365 to get more information regarding the health of your graft
• Provide support for decisions to minimize immunosuppression
• Revealing whether treatment for rejection has been successful without performing a biopsy
• Enabling early intervention, possibly improve long term patient outcomes

TruGraf is now covered by CMS!

• CPT Code: 81479
• Test Ordering Code: 30929

TruGraf^® will be reimbursed for kidney transplant patients covered by Medicare and Medicaid across the United States starting November 25, 2019.

Your doctor can contact Eurofins-Transplant Genomics and complete a patient requisition form. A TruGraf^® blood collection kit and completed requisition form will be mailed to your home or you can pick one up at your transplant center. You can then go to your transplant center or a Quest or LabCorp patient service center near you, just as you do for all your other routine blood work. After your blood is drawn the kit is mailed to TGI’s certified lab, the sample is analyzed, and a report sent to your doctor for review.

After kidney transplant, clinically unsuspected subclinical acute rejection , defined as the presence of histological lesions, indistinguishable from acute rejection in stable transplanted kidneys, occurs in 20% to 25% of patients in the first 12 to 24 months.