myTAIHEART Test Overview
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). No donor specimen is required.
How it Works
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 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.
myTAIHEART is performed in a highly-controlled environment within our CLIA compliant and CAP accredited clinical reference laboratory. Clinical and analytical studies have demonstrated the assay’s ability to generate precise, highly reproducible results, backed by correlation with clinical presentation and biopsy results. Additional multicenter clinical studies, both pediatric and adult, are currently underway.
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.
Patient blood samples are drawn at your hospital location, processed to plasma, and then shipped to the TAI Diagnostics Clinical Laboratory located in Milwaukee, Wisconsin.
At TAI Diagnostics, the patient’s cell-free DNA is isolated, quantified and processed with myTAIHEART’s proprietary chemistry and software analysis. Patient results are reported to the ordering physician/laboratory on the next business day after receipt at TAI Diagnostics.
Peer Reviewed Publications and Abstracts
- Zangwill S, Stamm K, Kindel S, Mahnke D, Goetsch M, Liang H, Ziegler E, Tomita-Mitchell A, Mitchell, M.E. Endomyocardial Biopsy – A Source of Heartache. The Journal of Heart and Lung Transplantation. 2018;37(4):S387-S388. doi:10.1016/j.healun.2018.01.997.
- Kindel S, Ragalie W, Zangwill S, Katz R, Tomita-Mitchell A, Stamm K, Mitchell, M.E. Early Changes in Donor Fraction Cell-free DNA in Newly Transplanted Pediatric Heart Transplant Patients. The Journal of Heart and Lung Transplantation. 2018;37(4):S400. doi:10.1016/j.healun.2018.01.1031.
- Ragalie W, Kindel S, Zangwill S, Mitchell M.E. Description of Longitudinal Measurement of Donor Fraction of Cell-Free DNA Following Rejection Treatment and Correlation to Clinical Outcomes. The Journal of Heart and Lung Transplantation. 2018;37(4):S402. doi:10.1016/j.healun.2018.01.1038.
- Ragalie W, Stamm K, Mahnke D, Liang H, Simpson P, Katz R, Tomita-Mitchell A, Kindel S, Zangwill S, Mitchell, M. E. Noninvasive Assay for Donor Fraction of Cell-Free DNA in Pediatric Heart Transplant Recipients. Journal of the American College of Cardiology. 2018;71(25):2982-2983. doi:10.1016/j.jacc.2018.04.026. PMID: 29929623
- Ragalie W, Stamm K, Hidestrand P, Hidestrand M, Mahnke D, Liang H, Goetsch M, Stendahl G, Simpson P, Katz R, Tomita-Mitchell A, Kindel S, Zangwill S, Mitchell, M.E. Novel Assay to Calculate Donor Fraction of Cell-Free DNA in Heart Transplantation. J Am Coll Cardiol. 2018;71(11):A764. doi:10.1016/s0735-1097(18)31305-6.
- Mitchell M.E, Hidestrand P, Simpson P, Goetsch M, Stendahl G, Liang H, Tweddell J, Tomita-Mitchell A, Hidestrand M, Zangwill, S. Quantification of Donor Specific Cell-Free DNA Yields Extremely High Sensitivity for Detection of Rejection Following Cardiac Transplantation. The Journal of Heart and Lung Transplantation. 2015;34(4):S53. doi:10.1016/j.healun.2015.01.132.
- Hidestrand M, Tomita-Mitchell A, Hidestrand P, Oliphant A, Goetsch M, Stamm K, Liang H, Castleberry C, Benson D.W, Stendahl G, Simpson P, Berger S, Tweddell J, Zangwill S, Mitchell M.E. Highly Sensitive Non-Invasive Cardiac Transplant Rejection Monitoring Using Targeted Quantification of Donor Specific Cell Free DNA. Journal of the American College of Cardiology. 2014;63(12):1224-1226. doi:10.1016/j.jacc.2013.09.029. PMID: 24140666
- Hidestrand M, Zangwill S, Tomita-Mitchell A, Oliphant A, Hidestrand P, Castleberry C, Stendahl G, Otto M, Liang H, Goetsch M, Ellis T, Shames B, Simpson P, Berger S, Tweddell J, Mitchell, M.E. 254 Highly Sensitive Transplant Rejection Surveillance Using Targeted Detection of Donor Specific Cell Free DNA. The Journal of Heart and Lung Transplantation. 2012;31(4):S91-S92. doi:10.1016/j.healun.2012.01.261.
- Castleberry C, Hidestrand M, Tomita-Mitchell A, Ellis T, Liang H, Harris S, Goetsch M, Stendahl G, Hoffmann R, Shames B, Tweddell J, Zangwill S, Mitchell, M.E. 407 Quantification of Circulating Cell-Free DNA in Pediatric Heart Transplant Recipients. The Journal of Heart and Lung Transplantation. 2011;30(4):S139. doi:10.1016/j.healun.2011.01.416.
New Customer Onboarding
Our team of healthcare professionals can answer any questions you have about offering the myTAIHEART Test at your institution. Specimen collection kits and training of your laboratory personnel will be provided.