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Lucid Diagnostics Obtains CE Mark for Esophageal Cancer Molecular Test

NEW YORK ─ Pavmed on Thursday announced that its subsidiary Lucid Diagnostics has obtained the CE mark for the EsoGuard Esophageal DNA Test, enabling its marketing in countries that accept the designation.

The EsoGuard molecular diagnostic test is performed on surface esophageal cells collected using Lucid’s EsoCheck Cell Collection Device, for which it obtained the CE mark in May.

The DNA test can serve as a screening tool to prevent esophageal cancer deaths through early detection of esophageal precancer and cancer in chronic heartburn patients that are at risk, Pavmed said, noting that the test was highly accurate at detecting these conditions in a 408-patient study published in Science Translational Medicine.

"We believe Europe will be an important market for EsoGuard and EsoCheck, where chronic heartburn is as ubiquitous and esophageal cancer [is] as deadly as it is in the US," Lishan Aklog, Pavmed’s chairman and CEO and Lucid's executive chairman, said in a statement.

A commercial launch for the test and collection device is planned for select European countries in the near future, and key opinion leaders for esophageal disease in Europe are participating in pivotal clinical trials, Aklog said.