myTAIHEART Test Overview
Product and Usage
The myTAIHEART test 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 8 days post-transplant. 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.
The myTAIHEART test 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 the myTAIHEART test 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
- 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. PE North, E Ziegler, DK Mahnke, KD Stamm, A Thomm, P Daft, M Goetsch, HL Liang, MA Baker, A Vepraskas, C Rosenau, M Dasgupta, P Simpson, ME Mitchell, A Tomita-Mitchell. PLOS ONE 15(1): e0227385. https://doi.org/10.1371/journal.pone.0227385
- Donor Fraction Cell-Free DNA and Rejection in Adult and Pediatric Heart Transplantation. Marc E Richmond, Steven D Zangwill, Steven J Kindel, Shriprasad R Deshpande, Jacob N Schroder, David P Bichell, Kenneth R Knecht, William T Mahle, Mark A Wigger, Nunzio A Gaglianello, Elfriede Pahl, Pippa M Simpson, Mahua Dasgupta, Paula E North, Mats Hidestrand, Aoy Tomita-Mitchell, Michael Edward Mitchell. The Journal of Heart and Lung Transplantation, 2019. DOI: https://doi.org/10.1016/j.healun.2019.11.015
- Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients. Steven D. Zangwill MD, Steven J. Kindel MD, William S. Ragalie MD, Paula E. North MD, Alyssa Pollow, Mats Hidestrand PhD, Aoy Tomita-Mitchell PhD, Karl D. Stamm PhD, Michael E. Mitchell MD. Pediatric Transplantion. 2019 Dec 11:e13622. DOI: https://doi.org/10.1111/petr.13622. PMID: 31825144
- Effect of Endomyocardial Biopsy on Levels of Donor-Specific Cell-Free DNA. Zangwill SD, Stamm KD, Hidestrand M, Tomita-Mitchell A, Mitchell ME. The Journal of Heart and Lung Transplantation. 2019 Oct.; 38 (10): 1118-1120 DOI: https://doi.org/10.1016/j.healun.2019.06.005 PMID: 31324442.
- Noninvasive Assay for Donor Fraction of Cell-Free DNA in Pediatric Heart Transplant Recipients. Ragalie W, Stamm K, Mahnke D, Liang H, Simpson P, Katz R, Tomita-Mitchell A, Kindel S, Zangwill S, Mitchell, M. E. Journal of the American College of Cardiology. 2018, Jun 26;71(25):2982-2983. DOI: https://doi.org/10.1016/j.jacc.2018.04.026. PMID: 29929623.
- Highly Sensitive Noninvasive Cardiac Transplant Rejection Monitoring Using Targeted Quantification of Donor-Specific Cell-Free Deoxyribonucleic Acid. Hidestrand M, Tomita-Mitchell A, Hidestrand PM, Oliphant A, Goetsch M, Stamm K, Liang HL, Castleberry C, Benson DW, Stendahl G, Simpson PM, Berger S, Tweddell JS, Zangwill S, Mitchell ME. Journal of the American College of Cardiology. 2014 Apr 1;63(12):1224-1226. DOI: https://doi.org/10.1016/j.jacc.2013.09.029. PMID: 24140666.
- Richmond, M.E., Kindel, S.J., Schroder, J.N., Deshpande, S.R., Bichell, D.P., Wigger, M.A., Knecht, K.R., Pahl, E., Gaglianello, N.A., Simpson, P.M., Mahle, W.T., Tomita-Mitchell, A., Zangwill, S.D., Mitchell, M.E., Increase in Donor Fraction Cell-Free DNA Correlates with Cellular and Antibody Mediated Rejection (ACR/AMR) in Adult and Pediatric Heart Transplant Recipients: DNA Based Transplant Rejection Test (DTRT)-A Prospective Blinded Multicenter NIH/NHLBI Funded Clinical Study. The Journal of Heart and Lung Transplantation, 2019. 38(4): p. S50.
- Zangwill, S.D., Kindel, S.J., Schroder, J.N., Bichell, D.P., Deshpande, S.R., Wigger, M.A., Richmond, M.E., Knecht, K.R., Gaglianello, N.A., Pahl, E., Simpson, P.M., Mahle, W.T., Tomita-Mitchell, A., Mitchell, M.E., Increase in Total Cell-Free DNA Correlates with Death in Adult and Pediatric Heart Transplant Recipients: DNA Based Transplant Rejection Test (DTRT)-A Prospective Blinded Multicenter NIH/NHLBI Funded Clinical Study. The Journal of Heart and Lung Transplantation, 2019. 38(4): p. S50-S51.
- P.E. North, A. Tomita-Mitchell, M. Goetsch, et al. Highly Sensitive Multiplex PCR Assessment of cfDNA Donor Fraction in Pediatric and Adult Heart Transplant Patients: Non-Invasive Risk Stratification for Rejection in an Expanded Patient Population and Transplant Window. Cutting Edge of Transplantation Meeting, Phoenix, AZ. February 2019.
- 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.
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.