myTAIHEART™

Highly Sensitive Heart Transplant Monitoring

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).

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 myTAIHEARTtest 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.

Resources

Peer Reviewed Publications and Presentations

  1. Hidestrand M, Tomita-Mitchell A, Hidestrand PM, et al. 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.
  2. Ragalie WS, Stamm K, Mahnke D, et al. 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.
  3. Castleberry C, Hidestrand M, Tomita-Mitchell A et al. 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.
  4. Hidestrand M, Zangwill S, Tomita-Mitchell A et al. 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.
  5. Hidestrand M, Zangwill S, Tomita-Mitchell A et al. 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.
  6. Mitchell M, Hidestrand P, Simpson P et al. 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.
  7. Ragalie W, Stamm K, Hidestrand P et al. 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.
  8. Zangwill S, Stamm K, Kindel S et al. 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.
  9. Kindel S, Ragalie W, Zangwill S et al. 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.
  10. Ragalie W, Kindel S, Zangwill S, Mitchell M. 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.

Assay Validation

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 are currently underway.

Testing Process

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. More details can be found in the Order Now section.

Overview

What is the myTAIHEART Test?

The myTAIHEART test is a simple non-invasive test that requires a small sample of blood. myTAIHEART measures the donor fraction of cell-free DNA (cfDNA) and aids in determining if a patient is at an increased risk for rejection of the transplanted heart.

Understanding cell-free DNA

In all people, cfDNA is released into the blood stream as a product of natural cell turnover or injury by illness or trauma. In heart transplant recipients, cfDNA is also released by the cells of the transplanted heart. The cfDNA released by the donor heart is genetically different than the cfDNA released by the patient’s native cells. The fraction of the recipient’s total cfDNA that is “donor specific” is known as the donor fraction %. Increased donor fractions of cfDNA indicated more damage to the transplanted heart and an increased risk for rejection.

Why myTAIHEART?

  • Can be used in patients as young as 2 months of age
  • Test as early as 7 days post-transplant
  • Non-invasive
  • Rapid results

 

Patient Resources

How does the myTAIHEART test work?

myTAIHEART test examines the cell-free DNA in your blood sample as a marker for injury to the transplanted heart. Your result is reported as a ratio of donor specific cell-free (cfDNA) to total cfDNA as the donor fraction (%) and categorizes you as at low or increased risk of rejection. Low donor fractions indicate less damage to the transplanted heart and a lower risk of rejection. Increased donor fractions indicate more damage to the transplanted heart and an increased risk for rejection.

Understanding your myTAIHEART results

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  • Negative Predictive Value (NPV) – The probability that a patient with low risk of rejection truly is not experiencing rejection.
  • Positive Predictive Value (PPV) – The probability that a patient with an increased risk of rejection is truly experiencing rejection.
  • Sensitivity – The ability of myTAIHEART to correctly identify patients experiencing rejection.
  • Specificity – The ability of myTAIHEART to correctly identify patients who are not experiencing rejection.

If you have been treated for rejection within 28 days before sample collection, you may have variably elevated donor fractions. Clinical judgment will be required for interpretation of results. Patients with a negative result should continue to be monitored according to standard clinical care. All results should be interpreted in the context of the patient’s clinical findings, history, and laboratory results.

Talk to your doctor about making myTAIHEART a routine part of your transplant care.

Testing Process

What is the testing process for myTAIHEART?

myTAIHEART testing begins with a simple blood draw on location at your hospital or clinical laboratory. Once the blood is collected, it is shipped to TAI Diagnostics clinical laboratory located in Wauwatosa, WI. Results are available the next business day after the sample arrives at TAI Diagnostics and your doctor will follow up with you to discuss your myTAIHEART results.

  • Overview

  • Resources

  • Testing Process

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