NEW YORK – Eurofins Viracor and Transplant Genomics said on Wednesday that the New York State Department of Health Clinical Laboratory Evaluation Program, or CLEP, has approved the Viracor TRAC donor-derived cell-free DNA test and TruGraf blood gene expression test, both of which assess rejection status in kidney transplant recipients.
With CLEP approval, the TRAC, or Transplant Allograft Rejection Check, and TruGraf tests are now available to patients in New York and in all 50 states.
The Viracor TRAC is a noninvasive dd-cfDNA method for early detection of rejection in renal transplant patients. The company said it has worked through the American Medical Association's Current Procedural Terminology system to secure a Proprietary Laboratory Analyses code for the test.
The TruGraf blood gene expression test offers clinicians the earliest opportunity to rule out subclinical acute rejection in kidney transplant recipients with stable renal function. Following a noninvasive blood draw, TruGraf can detect an early change in the patient's gene expression as the immune system activates prior to the clinically observable signs of acute rejection, Eurofins said.