biostudies-literatureCrespo-Leiro MGCareDx Inc2591-601https://www.ebi.ac.uk/biostudies/studies/S-EPMC5015661biostudies-literatureUnknown37(33)<h4>Aims</h4>A non-invasive gene-expression profiling (GEP) test for rejection surveillance of heart transplant recipients originated in the USA. A European-based study, Cardiac Allograft Rejection Gene Expression Observational II Study (CARGO II), was conducted to further clinically validate the GEP test performance.<h4>Methods and results</h4>Blood samples for GEP testing (AlloMap(®), CareDx, Brisbane, CA, USA) were collected during post-transplant surveillance. The reference standard for rejection status was based on histopathology grading of tissue from endomyocardial biopsy. The area under the receiver operating characteristic curve (AUC-ROC), negative (NPVs), and positive predictive values (PPVs) for the GEP scores (range 0-39) were computed. Considering the GEP score of 34 as a cut-European heart journalClinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II.PMC5015661NCT00761787Mohacsi PDeng MCParameshwar JSchulz UFiocchi RZuckermann ACrespo-Leiro MGElashoff BYee JPStypmann JLeprince PColvin MHoefer DRoss HVanhaecke JZakliczynski MBara CfalseClinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II.<h4>Aims</h4>A non-invasive gene-expression profiling (GEP) test for rejection surveillance of heart transplant recipients originated in the USA. A European-based study, Cardiac Allograft Rejection Gene Expression Observational II Study (CARGO II), was conducted to further clinically validate the GEP test performance.<h4>Methods and results</h4>Blood samples for GEP testing (AlloMap(®), CareDx, Brisbane, CA, USA) were collected during post-transplant surveillance. The reference standard for rejection status was based on histopathology grading of tissue from endomyocardial biopsy. The area under the receiver operating characteristic curve (AUC-ROC), negative (NPVs), and positive predictive values (PPVs) for the GEP scores (range 0-39) were computed. Considering the GEP score of 34 as a cut-2016-01-01T00:00:00Z2016 Sep2026-04-07T19:12:37.066Z2019-03-26T23:06:41ZS-EPMC50156612674662910.1093/eurheartj/ehv682