Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

The AlloSure test has been approved for Medicare coverage for clinical use when a physician
determines there is a need to assess the probability of allograft rejection in kidney
transplant recipients. Accurate and timely detection of allograft rejection and effective
treatment are essential for long-term survival of renal transplants. The DART study validated
the ability of the non-invasive AlloSure test to measure donor-derived cell-free DNA
(dd-cfDNA) to discriminate active rejection in a renal transplant recipient. Use of the test
will inform and may reduce invasive percutaneous renal biopsy procedures among patients with
risk of rejection.

KOAR Inclusion Criteria:

1. Medicare-covered (Part B) renal transplant recipients selected by their providers to
receive AlloSure testing as part of their practical care beginning by 2 months
post-transplantation.

2. Patient's health care provider adopts and intends to apply the center's AlloSure
Routine Testing Schedule as part of the information used to manage the patient.

3. Subjects willing to provide written informed consent to participate.

KOAR Exclusion Criteria:

1. Renal transplant recipients without Medicare (Part B) coverage.

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Exclusions for AlloSure® Intended Use

Specimens from patients for whom any of the following are true will not be tested:

1. Recipients of transplanted organs other than kidney

2. Recipients of a transplant from a monozygotic (identical)

3. Recipients of a bone marrow transplant

4. Recipients who are pregnant

5. Recipients who are under the age of 18

6. Recipient who are less than 14 days post-transplant