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XDx's AlloMap heart transplant blood test gets FDA nod

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for XDx's AlloMap molecular expression test. It determines which heart transplant patients are the least likely to suffer from transplant rejection, in conjunction with standard clinical assessment. The test has been available through Brisbane, California-based XDx's CLIA-certified laboratory since January 2005. Allograft measures RNA levels of 11 rejection biomarker genes and nine control genes, to produce a single test score ranging from 0-40 which discriminates between the absence or presence of moderate-to-severe acute cellular rejection. As a blood test, it is less invasive than the standard endomyocardial biopsy test used to monitor heart transplant patients for rejection.

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