Abstract
s S33 Results: Four of the six HTG EdgeSeq and NanoString nCounter recalibrated panels had negative predictive value (NPV) of at least 99% when tested in the replication cohort. The positive predictive value (PPV) was between 4 and 5% for all panels. Combining 2 or 3 of the panels into an ensemble improved the PPV slightly to 7% while keeping the NPV at > 99%. Sensitivity for detection of true rejection positives was 100% for most panels. These performance characteristics apply to all timepoints post-transplant. Conclusion: Blood-based biomarkers to monitor for absence of acute cardiac rejection have been identified and replicated, then transferred to and tested on two clinically relevant platforms. The HTG assay is being deployed at the local clinical laboratory. The team is currently designing a North American clinical trial to assess the validity of the selected biomarkers in a clinical setting. Once clinically validated, the assay and instrument will be deployed to other transplant centres.
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