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Analytical Validation of Esopredict, an Epigenetic Prognostic Assay for Patients with Barrett’s Esophagus

Authors :
Sarah Laun
Francia Pierre
Suji Kim
Daniel Lunz
Tara Maddala
Jerome V. Braun
Stephen J. Meltzer
Lisa Kann
Source :
Diagnostics, Vol 14, Iss 18, p 2003 (2024)
Publication Year :
2024
Publisher :
MDPI AG, 2024.

Abstract

EsopredictTM is a prognostic assay that risk-stratifies Barrett’s esophagus patients to predict future progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). Established based on foundational studies at Johns Hopkins University, a risk algorithm was developed and clinically validated in two independent studies (n = 320). EsopredictTM is currently offered as a clinical test under the Clinical Laboratory Improvement Amendments (CLIA) guidelines. Here we present the analytical validation by repeated testing of FFPE tissues (n = 26 patients), cell lines, and contrived DNA controls to determine assay performance regarding analytical sensitivity (as defined by the limit of detection (LOD)), analytical specificity (as defined by the limit of blank (LOB)), accuracy as determined from the average positive and negative agreement, repeatability, and reproducibility. The LOD for the assay at 1.5% DNA methylation was significantly higher than the LOB, as determined by an unmethylated DNA control (0% methylated DNA). Inter- and intra-assay average positive agreement (APA) were 88% and 94%, respectively, while average negative agreement (ANA) values were 90% and 94%, respectively. Average inter- and intra-assay precision were TM is a highly reproducible, sensitive, and specific risk categorization assay for the prediction of progression to HGD or EAC within 5 years.

Details

Language :
English
ISSN :
20754418
Volume :
14
Issue :
18
Database :
Directory of Open Access Journals
Journal :
Diagnostics
Publication Type :
Academic Journal
Accession number :
edsdoj.9c432a78a91f4fd6acab1efd58f9922e
Document Type :
article
Full Text :
https://doi.org/10.3390/diagnostics14182003