Available This Spring
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).
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 damage to the transplanted heart and an increased risk for rejection.
The US Food and Drug Administration (FDA) does not require this test to go through premarket FDA review, and it has not been cleared or approved by the FDA. TAI Diagnostics is accredited by the Clinical Laboratory Amendments of 1988 (CLIA) and College of American Pathologists (CAP) and is therefore qualified to perform high complexity clinical laboratory testing. This test is intended for clinical use. It should not be regarded as investigational or for research.