Indications and Special Considerations AlloMap testing is indicated for use in detecting the absence of acute cellular rejection (ACR) in clinically stable cardiac transplant patients who are: ≥15 years of age >2 months post-transplant Special consideration in interpreting results should be given to patients who are: On corticosteroid dosage of >20 mg/day of prednisone or equivalent <30 days post-blood transfusion <21 days post-rejection therapy

AlloMap molecular expression testing uses a simple blood sample to translate the complex signals from multiple immune system genes and pathways associated with heart transplant rejection into an objective, actionable score. AlloMap testing was developed and validated in a prospective, blinded and powered study based on samples and clinical data collected from the multi-center CARGO study.

The AlloMap test is performed at the CLIA-certified XDx Reference Laboratory in Brisbane, California, where the test was developed and validated.

The AlloMap test is a 20-gene, real-time, quantitative polymerase chain reaction (qRT-PCR) assay. AlloMap testing applies a proprietary mathematical algorithm that combines the gene expression values from genes associated with cardiac allograft rejection and generates a single clinically actionable score. Results are reported as an AlloMap score - an integer ranging from 0 to 40.

The AlloMap Report is delivered via fax to the treating physician, who interprets it in light of the patient’s clinical picture and other test results. After testing, in most circumstances, XDx bills the patient's insurer directly.

Transplant clinics can include AlloMap testing in a personalized noninvasive management protocol starting at > 2 months post-transplant. Using AlloMap testing, physicians can confidently identify patients at very low risk for acute cellular rejection.

Clinics are using AlloMap testing for:

	Longitudinal non-invasive surveillance for ACR
	Monitoring for ACR while modifying immunosuppressant regimen
	Identify patients early post-transplant who belong to a very low risk group for ACR within the next few months
	Alternative to biopsy in patients with access problems
	Provide additional information in the management of patients with “mild rejection” of biopsy or unclear clinical presentation

Interpreting AlloMap Test Results In conjunction with clinical judgment and assessment of graft function, AlloMap testing can reliably identify those patients who are at very low risk for ACR. The AlloMap test report presents the current AlloMap score and corresponding 95% confidence interval. The report also plots the AlloMap scores for tests performed in the prior 12 months. With this information the physician can assess the patients risk for ACR longitudinally.

Example of AlloMap test report Click here to enlarge (PDF format).

Find out more: Genes & Pathways The AlloMap Testing Process XDx Reference Laboratory

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