New ISHLT Guidelines Support Use of CareDx’s HeartCare Solutions, AlloMap and AlloSure, in Routine Monitoring of Heart Transplant Patients – Read More

What is HeartCare?

HeartCare is a non-invasive leading indicator of graft injury and immune activation/quiescence.

HeartCare is a multi-modality approach that utilizes two complementary technologies.

AlloSure HEART Logo

AlloSure Heart provides peace-of-mind that injury is unlikely with dd-cfDNA levels below 0.15%.

 

*Clinical correlation is required.
As defined by their institutional protocol.
Interpretation of AlloSure in Heart Transplantation graph is based on data from the D-OAR study.

AlloMap HEART Logo

AlloMap Heart is an established standard in heart transplant.

HeartCare Multi-Modality Surveillance is Equally Effective, While Requiring Significantly Fewer Biopsies

HeartCare cfDNA Chart

HeartCare cfDNA Chart

This study1 compares paired use of AlloSure dd-cfDNA and AlloMap GEP testing as compared to GEP testing alone – this resulted in similar post-transplant survival, rejection free survival and graft function at 1 year, while requiring significantly fewer endomyocardial biopsies.

HeartCare Helps Clinicians Identify Quiescent Patients and Those at Risk for Graft Injury

HeartCare Has Been Clinically Validated in Multi-Center Prospective Studies Including >4,500 Patients

AlloSure Heart Has Been Clinically Validated to Differentiate Rejection vs No Rejection

AlloSure Heart was clinically validated in the multi-center prospective D-OAR study.2

Clinical validation:

  • dd-cfDNA levels are over 2X greater in the rejection groups vs the no rejection group
  • No rejection vs all rejection, p= 0.005

ACR = Grade 2R and Grade 3R
Grades 0R and 1R are in the No Rejection group
AMR = pAMR1 and pAMR2

AlloMap’s Non-invasive Surveillance for Rejection Has Proven to Be Non-inferior to Invasive Biopsy3,4

AlloSure Heart Can Provide Information on DSA and CAV

AlloMap Heart Can Provide Information on CMV Infection and Malignancy

Sample Collection and Draw Instructions

HeartCare

Watch the HeartCare specimen collection and shipping video and download step by step instructions.

AlloMap

Watch the AlloMap specimen collection and shipping video and download step by step instructions.

References

1Henricksen EJ, Moayedi Y, Purewal S, et al. Combining donor derived cell free DNA and gene expression profiling for non-invasive surveillance after heart transplantation [published online ahead of print, 2022 May 12]. Clin Transplant. 2022;e14699. doi:10.1111/ctr.14699
2 Khush KK, Patel J, Pinney S, et al. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019;19(10):2889-2899. doi:10.1111/ajt.15339. D-OAR is a sub-study of the Outcomes AlloMap Registry (OAR).
3 Pham MX, Teuteberg JJ, Kfoury AG, et al. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010;362(20):1890-1900. doi:10.1056/NEJMoa0912965.
4 Kobashigawa J, Patel J, Azarbal B, et al. Randomized pilot trial of gene expression profiling versus heart biopsy in the first year after heart transplant: early invasive monitoring attenuation through gene expression trial. Circ Heart Fail. 2015;8(3):557-564. doi:10.1161/CIRCHEARTFAILURE.114.001658.
5 Teuteberg, J., Kobashigawa, J., Shah, P., Ghosh, S., Ross, D., DePasquale, E., & Khush, K. (2021). Donor-Derived Cell-Free DNA Predicts De Novo DSA after Heart Transplantation. J Heart Lung Transplant, 40(4), S30.
6[ABSTRACT] DePasquale E, Kobashigawa J, Pinney S, Khush K. dd-cfDNA as a Risk Factor for Initiating De-Novo Donor Specific Antibodies in Heart Transplantation [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/dd-cfdna-as-a-risk-factor-for-initiating-de-novo-donor-specific-antibodies-in-heart-transplantation/. Accessed August 3, 2022.
7 Holzhauser L, Clerkin KJ, Fujino T, et al. Donor-derived cell-free DNA is associated with cardiac allograft vasculopathy. Clin Transplant. 2021;35(3):e14206. doi:10.1111/ctr.14206.
8[ABSTRACT]  Franzwa, J., Laxson, C., Chawla, R., Nabeel, Y., & Johnson, F. (2018). Low Allomap Ordinal and Variability Scores Are Associated with Increased Malignancy Post Heart Transplant. The J Heart Lung Transplant, 37(4), S335-S336.
9 Kanwar, M. K., Khush, K. K., Pinney, S., Sherman, C., Hall, S., Teuteberg, J., … &Kobashigawa, J. (2021). Impact of cytomegalovirus infection on gene expression profile in heart transplant recipients. J Heart Lung Transplant, 40(2), 101-107.