www.fdanews.com/articles/203152-pavmed-earns-ce-mark-for-esophageal-cancer-test
PAVmed Earns CE Mark for Esophageal Cancer Test
June 14, 2021
PAVmed subsidiary Lucid Diagnostics has obtained CE mark certification for EsoGuard, a DNA test used to detect esophageal cancer.
The molecular diagnostic, which tests esophageal cells gathered using the company’s noninvasive cell-collection device, is designed to screen at-risk chronic heartburn patients early on for esophageal precancer and cancer.
EsoGuard is the first commercially available diagnostic test that could be used as a widespread screening tool for esophageal cancers, the company said, adding that the test was shown to be “highly accurate” in a 408-patient trial.