Product and Usage
myTAIHEART is a laboratory developed test (LDT) which examines the cell-free DNA in a patient blood sample as a marker for transplanted organ injury. This test is intended to aid in the identification of heart transplant recipients who have a low probability of moderate/severe acute cellular rejection (Grade 2R or higher) at the time of testing in conjunction with standard clinical assessment. This test is indicated for use in heart transplant recipients who are 2 months of age or older and at least 1 week post-transplant (≥7 days).
The myTAIHEART test uses a panel of highly informative single nucleotide polymorphisms to quantitatively genotype cell-free DNA (cfDNA) in the patient’s plasma. This measurement accurately distinguishes “donor specific” cfDNA originating from the engrafted heart versus “self specific” cfDNA originating from the recipient’s native cells. The myTAIHEART test reports the ratio of donor specific cfDNA to total cfDNA as the donor fraction (%) and categorizes the patient as at low or increased risk of moderate/severe acute cellular rejection: low donor fractions indicate less damage to the transplanted heart and a lower risk for rejection, while increased donor fractions indicate more damage to the transplanted heart and an increased risk for rejection.
This test was developed and its performance characteristics determined by TAI Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.