Company Readies for Commercial Launch of TruGraf™ Blood Test for the Diagnosis of Rejection Following Kidney Transplantation
Brookline, MA, April 30, 2015 —
Transplant Genomics Inc. (TGI) has announced the appointment of Dr. Roy First as its Chief Medical Officer as the company moves toward the launch of its first product, the TruGraf Blood Test. Most recently, Dr. First was the Vice President and Therapeutic Area Leader, Transplantation, at Astellas Pharma Global Development, Inc. He is a past President of the American Society of Transplantation (AST) and recipient of the AST Lifetime Achievement Award. His distinguished clinical and academic career includes professional appointments at major academic institutions and important roles in many organizations, such as the United Network for Organ Sharing, the U.S. Food and Drug Administration and the National Institutes of Health.
“I am very excited to be joining this innovative company on the cutting edge of applying genomic biomarkers to post-transplant management,” commented Dr. First. “The ultimate goal is to be able to detect and respond to early signs of graft injury so as to improve management of the patient as well as graft outcomes. I am convinced that TruGraf has such capabilities and has the potential to extend graft and patient lives, and reduce healthcare costs.”
“Roy is a widely respected leader in transplantation with a deep understanding of the field, and we are thrilled to have him join our team,” explained Stan Rose, PhD, President & CEO of Transplant Genomics. “As we prepare for the commercial launch of our tests, his guidance will be invaluable in implementing our clinical programs, interacting with the transplant community and with industry partners, and in designing and executing future studies to demonstrate clinical utility, improved outcomes and cost-effectiveness.”
About the TruGraf Blood Test
TruGraf is a blood test for kidney transplant recipients. TruGraf uses gene expression profiling to provide decision support for physicians in their efforts to personalize immunosuppressive therapy. Performed as a service through the CLIA lab at TGI, the test offers a noninvasive way to diagnose rejection following kidney transplantation. The first application of the test will be to differentiate rejection from other causes of dysfunction in patients who present with elevations in serum creatinine.
TruGraf results will be used in combination with standard tests to help clarify causes of dysfunction. One advantage will be to avoid high risk or complicated biopsies such as in patients on anticoagulation therapy or with other possible contraindications to immediate biopsy. TruGraf has been clinically validated in multiple independent studies, including populations with diverse ethnicities. In addition, ongoing studies are being performed to validate future use of this test to predict clinical acute rejection, and to diagnose subclinical rejection in the presence of a normal serum creatinine (similar to diagnosing rejection on a protocol surveillance biopsy).
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 immunosuppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA lab in Pleasanton, CA. www.transplantgenomics.com