This article summarizes the third step in the development and validation of a nonendoscopic, minimally invasive molecular test to detect a precursor to esophageal adenocarcinoma: Barrett’s esophagus. Esophageal adenocarcinoma is a rare but lethal malignancy with rapidly rising incidence. When detected early its outcomes are substantially better, and it can be prevented by the endoscopic treatment of its precursor lesion: Barrett’s esophagus with dysplasia.
This study is the next step in the development of a molecular test for BE detection. In our previous 2 papers, we discovered and pilot tested methylated DNA markers and narrowed down the panel of MDMs to 5. In this study we trained a slightly modified panel of MDMs on a training set and then tested its performance in an independent test set. We also streamlined the DNA extraction of samples and the testing algorithm.
A 5 MDM panel had a sensitivity of 93% at a specificity of 90% in the test set. Performance was not affected by age, sex, BMI, or smoking history. Performance was affected by BE segment length where sensitivity was lower at 80% for short segment BE. The test was well tolerated and safe when performed by RNs in the clinic.
The next step in this journey is the setting of the algorithm, which will be used to make the determination of test positivity and negativity, followed by independent validation.
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