Clinically viable blood test for donor-derived cell-free DNA
Can vastly reduce the need for routine surveillance biopsies following heart transplantation
Boston, MA (April 30, 2021) - A new study, presented today at the AATS 101st Annual Meeting, shows that non-invasive cell-free DNA tests can reduce the need for regular surveillance biopsies to detect early rejection in heart transplant patients. The study was the first of its kind to be performed on both adult and pediatric patients.
Pediatric and adult heart transplant recipients were recruited prospectively from eight participating sites and followed longitudinally for at least 12 months with serial plasma samples collected immediately prior to all endomyocardial biopsies. Structured biopsy results and clinical data were collected and monitored by an independent clinical research organization (CRO).
For all patients taken together in comparison to the composite biopsy outcome using repeated measures, donor fraction (DF) cfDNA at a pre-defined cut point of 0.14 had a sensitivity of 67%, a specificity of 79%, a PPV of 34% and a NPV of 94% with an area under the curve (AUC) of 0.78 (p END
Pediatric and adult heart transplant recipients were recruited prospectively from eight participating sites and followed longitudinally for at least 12 months with serial plasma samples collected immediately prior to all endomyocardial biopsies. Structured biopsy results and clinical data were collected and monitored by an independent clinical research organization (CRO).
For all patients taken together in comparison to the composite biopsy outcome using repeated measures, donor fraction (DF) cfDNA at a pre-defined cut point of 0.14 had a sensitivity of 67%, a specificity of 79%, a PPV of 34% and a NPV of 94% with an area under the curve (AUC) of 0.78 (p END