AlloMap Molecular Expression Testing

AlloMap molecular expression testing, developed and commercialized by CareDx, formerly known as XDx, is a gene expression profiling test to identify heart transplant recipients with a low probability of one type of transplant rejection. The test is performed on a blood sample, providing a non-invasive test to help manage the care of patients post transplant. Prior to the availability of this test, the primary method for managing heart transplant rejection was the invasive technique of endomyocardial biopsy.

Test results are reported as a single score indicating the probability of moderate/severe acute cellular rejection (ACR). The performance characteristics of the test make it best suited to help indicate that acute cellar rejection is not present. The score is based on the amount of RNA from each gene in a 20-gene panel comprising 11 rejection-related genes and 9 genes used for normalization and quality control. Many of the rejection-related genes are associated with biological pathways involved in the immune response and rejection processes.

The test score is used, along with other standard clinical assessments, to evaluate the patient’s probability of acute cellular rejection and the need for additional evaluations. This test is not designed to be informative about other forms of heart rejections such as antibody-mediated rejection (AMR) or cardiac allograft vasculopathy (CAV).

AlloMap has been commercially available since 2005 as a CLIA approved Laboratory Developed Test (LDT) and was cleared by the U.S. Food and Drug Administration (FDA) in 2008 as a Class II Medical Device. It is available only from the CareDx Reference Laboratory in Brisbane, CA.

The use of the test is described in the recommendations for the non-invasive monitoring of acute heart transplant rejection in the first evidence-based clinical practice guidelines for the care of heart transplant recipients issued by the International Society of Heart and Lung Transplantation.

CareDx, Inc., announced on June 3, 2014 that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission relating to the proposed initial public offering of shares of its common stock.

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