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CARGO II: Gene expression test effective in patients in Europe

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Results from the CARGO II European-based study independently confirm and extend positive test performance characteristics previously established in the US-based CARGO study, suggesting that the AlloMap noninvasive gene expression test may be effective for heart transplant recipients worldwide.

The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II results were presented at a late-breaking clinical trial session during the International Society for Heart and Lung Transplantation 32nd Annual Meeting and Scientific Sessions.

The study was designed to provide independent evidence of the clinical performance of AlloMap Molecular Expression Testing (XDx), assessing the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from AlloMap. Researchers reported data on 741 heart transplant recipients aged at least 18 years from 17 participating centers from 2006 to 2011. More than 8,000 study visits were evaluated, including more than 3,300 surveillance biopsies, AlloMap test samples and other clinical observations.

Results showed mean test scores for samples associated with acute cellular rejection grades of at least 3A were significantly higher than test scores from samples of patients with no rejection seen on histology. From 55 days to 6 months after transplant, 1.9% of biopsies had a grade of at least 3A vs. 5.8% of rejections. At more than 6 months after transplant, biopsies with a grade of at least 3A increased to 2.1%. A mean score of 25 was found in blood samples from 41 patients with no rejection. These scores were matched with a mean score of 29 from unique patients with confirmed grades of acute cellular rejection (ACR) of at least 3A. A negative predictive value of 98.4% at the most often used ACR threshold was demonstrated by AlloMap at 2 to 6 months after transplant.

Jörg Stypmann, MD, transplant cardiologist in the department of cardiology and angiology of the University Hospital Munster, Germany, said in a press release: “The surveillance of heart transplant recipients typically has required heart tissue obtained by biopsies to detect asymptomatic acute rejection, which can lead to graft dysfunction or loss. We believe that a sufficiently accurate blood test, such as AlloMap, especially in the context of the low prevalence of asymptomatic rejection, can provide a safer alternative to biopsy in stable, low-risk patients.”

AlloMap Molecular Expression testing is a noninvasive gene expression test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate or severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. The test was cleared by the FDA in 2008 and received a CE mark in 2011.

Disclosure: Dr. Stypmann reports grant support from XDx.