TAI Diagnostics Announces Publication of Analytical and Clinical Validation Studies Supporting Use of the myTAI-HEART Test for Non-Invasive Post-Transplant Assessment of Rejection Probability in Adult and Pediatric Heart Transplant Patients

MILWAUKEE--(BUSINESS WIRE)-- TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Cell-Free DNA Donor Fraction Analysis in Pediatric and Adult Heart Transplant Patients by Multiplexed Allele-Specific Quantitative PCR: Validation of a Rapid and Highly Sensitive Clinical Test for Stratification of Rejection Probability“ in the January 13, 2020 issue of the journal, PLOS ONE.

The clinical validation study conducted by TAI Diagnostics and researchers at the Medical College of Wisconsin used the myTAI_HEART^® test to quantify changes in the cell-free DNA donor fraction (DF) of blood plasma samples from 76 pediatric and adult heart transplant recipients and included 158 matched endomyocardial biopsy-plasma pairs. The publication provides details of the development and use of the myTAI_HEART test including parameters related to blood sample collection and preparation, automated cell-free DNA extraction and donor fraction (DF) calculation.

The study concludes: “The intended use of this highly sensitive, clinically accredited PCR-based assay for selective damage to a donor heart is designed conservatively to stratify low versus increased probability of moderate to severe acute cellular rejection (ACR) in heart transplant recipients with 100% NPV based on a DF cut-off value. The analytical and clinical validation data reported herein strongly supports its validity in doing so. This test is validated for clinical diagnostic use in heart transplant recipients who are 2 months of age or older and as early as 8 days post-transplant. It significantly expands the window of opportunity for non-invasive transplant rejection assessment to infants and young children and to all recipients, adult or pediatric, into the critical early post-transplant period in which rejection is most common.”

Transplant rejection is the major determinant of patient outcome following transplantation. Routine monitoring is necessary to detect and treat organ rejection as early as possible while balancing inherent risks of over immunosuppression. The current gold standard for monitoring the status of rejection is invasive tissue biopsy of the transplanted organ. Tissue biopsy, however, is subject to sampling error, can be a lagging indicator of organ damage, and is expensive for the patient and healthcare system. Further, as an invasive procedure, biopsy presents significant health risk to the recipient patient and cannot be repeated frequently. The myTAI_HEART test requires only a small sampling of peripheral blood and is designed to provide a non-invasive measurement of selective cellular injury to the allograft heart by quantifying donor-specific cell-free DNA released from injured cells of the donor organ into the recipient’s blood. Lead author Dr. Paula North states, “We are honored to bring this high-performing test to patients young and old, reducing the need for invasive biopsy and offering practical potential for earlier rejection detection and treatment. It provides a valuable new tool in the game book of health care providers as they seek to improve and extend the lives of the heart transplant patients under their care.”

About TAI Diagnostics

TAI Diagnostics develops and commercializes cell-free DNA technology for monitoring the health of transplanted organs, providing testing services through their CLIA/CAP accredited Clinical Reference Laboratory in Milwaukee, Wisconsin. The myTAI_HEART 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.

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