Overview

The AlloMap Test

Performed in the CareDx® CLIA, CAP-accredited clinical laboratory, AlloMap® is a blood test in-tended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing, in conjunction with standard clinical assessment.

Summary and explanation of AlloMap

The AlloMap test is a panel of 20 gene assays, 11 informative and 9 used for normalization and quality control, which produces gene expression data used in the calculation of an AlloMap Score. The AlloMap Score ranges from 0-40.

The AlloMap test is based on quantitative real-time polymerase chain reaction methodology (qRT-PCR) using RNA purified from peripheral blood mononuclear cells (PBMC).

A blood sample is collected in a BD Vacutainer® CPT Cell Preparation tube (Becton Dickinson, NJ) with sodium citrate anticoagulant. PBMC are isolated, lysed and the released RNA is stabilized and frozen (PBMC lysate). At the CareDx laboratory in Brisbane, CA, RNA is purified from the PBMC lysate. Complementary DNA (cDNA) is subsequently generated from the RNA for use in the qRT-PCR. Quality control checks are performed on the resulting gene expression data and the AlloMap Score is calculated.