AlloMap Molecular Expression Testing

New from XDx – Announcing…

AlloMap molecular expression testing is now available for cardiac transplants as early as 2 months post cardiac transplant!

For cardiac transplant patients, acute cellular rejection is most worrisome in the first months post transplant. As of Monday, August 21, 2006, AlloMap molecular expression testing is available to help you monitor patients as early as 2 months post cardiac transplant. When combined with patient assessment, AlloMap testing can provide the confidence you need to rule out acute cellular rejection.

Freedom from Future Rejection

A CARGO sub-study showed that patients with scores < 20 in the first 6 months post transplant were free from ACR ≥ 3A(2R) for the next 80 days (~12 weeks)¹.

¹ Data on File

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AlloMap Testing Description

	Genes & Pathways
	The AlloMap Testing Process
	XDx Reference Laboratory

Developing AlloMap Testing

Billing & Reimbursement

Existing customers: click here to order supplies.

XDx Reference Laboratory Certification Information

Lab Directors:
Patrick Joseph, MD
Judith Wilber, PhD, D(ABMM)

CLIA Number: 05D1029609

California License
(CLF) Number: 332008

The XDx Reference Laboratory

AlloMap testing is performed only in the CLIA-certified XDx Reference Laboratory, where the assay was developed, characterized, and validated clinically and analytically. The XDx Reference Laboratory performs quantitative real-time polymerase chain reaction assays (qRT-PCR), the proven methodology for sensitive, specific, and reproducible gene expression measurement. XDx has optimized and standardized the performance of AlloMap test processes and implemented extensive quality control procedures.

Quality Control Testing

The relative expression of the nine quality control genes, six of which are also normalization genes, on the AlloMap testing panel provides data from which the quality of all aspects of the testing processes can be determined. These include:

	RNA quantity and quality There must be a sufficient quantity of extracted and purified RNA to perform 60 qRT-PCR reactions (20 genes in triplicate). The RNA must meet acceptance criteria for purity, which includes testing for contaminating genomic DNA.
	Verifying assay ranges The relative quantity of each control gene product must fall within a predetermined expected range.
	Efficiency of qRT-PCR QC procedures determine the acceptability of output of the polymerase chain reaction procedures, which are expected to double the target material every cycle.
	Verifying reproducibility Each of the 20 genes is tested in triplicate. The precision of the 3 replicates must be within a specified range.