Surveillance HeartCare® Outcomes Registry

HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information to
help clinicians to more comprehensively monitor heart transplant recipients for allograft
rejection. An approach to surveillance using HeartCare provides information from two
complementary measures; AlloMap is a gene-expression profile based measure of host immune
activity and risk of acute rejection. AlloSure-Heart monitors graft injury. AlloMap is the
first FDA cleared test and is the only non-invasive, blood test method recommended in the
International Society for Heart and Lung Transplantation (ISHLT) guidelines for surveillance
of heart transplant recipients for rejection. AlloSure-Heart measures donor-derived cell-free
DNA (dd-cfDNA) to help discriminate acute cellular rejection and antibody-mediated rejection
from no rejection. Patients who receive HeartCare, as part of their post-transplant
management, will give informed consent for information on their outcomes and other relevant
clinical information, found in their medical records, to be entered into a SHORE database for
purposes of the study.

Inclusion Criteria:

1. Patients who are 15 years of age or older at the time of blood draw.

2. Heart transplant recipients who are selected by their health care provider to be
managed with HeartCare.

3. Patients who are selected by their health care provider to be managed following the
Heart Routine Testing Schedule (HARTS) or a derivative of the schedule that has been
defined by the provider.

4. Patients who provide written informed consent.

5. Patients who have HeartCare initiated within 30 days of signing the informed consent
form.

Exclusion Criteria:

1. Patients who are less than 15 years of age at the time of blood draw.

2. Heart transplant recipients who are not managed with HeartCare.

3. Patients who are not managed following the Heart Routine Testing Schedule (HARTS) or a
derivative of the schedule that has been defined by the provider.

4. Patients who are pregnant at the time of blood draw.

5. Patients who do not provide written informed consent.