Press release

 NIH-NHLBI Clinical Study Reports on Donor Fraction Cell-Free DNA Analysis as an Indicator of Heart Transplant Rejection in Adult and Pediatric Patients

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TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Donor Fraction Cell-Free DNA and Rejection in Adult and Pediatric Heart Transplantation” in the November 29th online articles in press version of The Journal of Heart and Lung Transplantation. The paper highlights findings from AIM 1 of the NIH funded, DNA-Based Transplant Rejection Test (DTRT) study, conducted among seven established U.S. heart transplant centers.

The prospective, blinded, observational DTRT study used the myTAIHEART® test to investigate the utilization of cell-free DNA donor fraction (DF), quantified in blood samples from heart transplant recipients, as a biomarker for rejection. The data was generated from a final population analysis of 174 patients. The paper concludes: “DF is associated with both antibody mediated rejection and acute cellular rejection in adult and pediatric patients. Sample preparation appears to be critical and the plasma protocol demonstrates significant apparent advantages over the whole blood protocol. Further studies with larger numbers of higher grades of rejection and more clinically associated information are required and are currently underway.”

Frank Langley, CEO of TAI Diagnostics, stated, “As a co-sponsor of this NIH multicenter study, TAI is pleased to recognize the achievements of the NIH study team and the results providing support for the use of cell-free DNA donor fraction as a biomarker for transplant surveillance.”

Transplant rejection is the major determinant of patient outcome and routine monitoring is necessary to detect and treat rejection. The current gold standard for monitoring the status of organ rejection is tissue biopsy. However, tissue biopsy is subject to sampling error, can be a lagging indicator of organ damage, is expensive for the patient and healthcare system, and as a very invasive procedure presents significant risks to the patient. The myTAIHEART® test is performed using a small blood sample and has been developed to provide a non-invasive measurement of selective allograft heart injury through quantification of donor-specific cell-free DNA which is released from injured cells of the donor organ into the recipient’s blood.

About TAI Diagnostics

TAI Diagnostics develops and commercializes cell-free DNA technology for monitoring the health of transplanted organs. TAI provides testing services through their CLIA/CAP accredited Clinical Reference Laboratory in Milwaukee, Wisconsin. The myTAIHEART® test is available for use in post-transplant monitoring of adult and pediatric heart transplant patients and is used at leading heart transplant centers throughout the United States.