Press release

Clinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients

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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 Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients” in the December 11th open access version of Pediatric Transplantation, the official journal of the International Pediatric Transplant Society.

The publication provides results from a prospective study on the early postoperative surveillance of heart health. The pilot study was conducted with 17 heart transplant recipients at the Herma Heart Institute, Children’s Wisconsin. Blood samples were collected at 3 time points within 10 days of transplantation to quantify changes in the cell-free DNA donor fraction (DF) using the myTAIHEART® test.

The publication concludes: “In this study, we found that the pattern of decline in DF during the first post-transplant week along with the level of total cell-free DNA (TCF) may be prognostically important. Marked elevation of TCF at 1 week following heart transplant and a rise in DF from 4-8 days are associated with poor outcomes. Larger studies are needed to further understand the relationship and prognostic significance of the TCF and DF early post-heart transplant.”

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 an 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.