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Lucid Diagnostics Files 510(k) Application for Barrett's Esophagus Detection Tool

NEW YORK (360Dx) – Lucid Diagnostics said today that it has submitted a 510(k) application to the US Food and Drug Administration for the EsoCheck Cell Collection Device, which detects Barrett's Esophagus (BE) in patients at risk of esophageal cancer.

Lucid, a subsidiary of PavMed, has developed EsoCheck as a two-part system that uses a balloon catheter to collect cells from a targeted region of the esophagus without the need for endoscopy. Researchers then use the EsoCheck Dx, a methylated DNA biomarker test, to detect BE in a patient.

Lucid believes EsoCheck has the potential to save lives through the early detection of BE, which clinicians can monitor and treat with non-surgical approaches if it is detected before it becomes cancerous.

"The EsoCheck CCD 510(k) submission is a critical first step in realizing the enormous potential of this groundbreaking alternative to endoscopy," PavMed CEO and Chairman Lishan Aklog said in a statement.

According to Lucid, EsoCheck is progressing through a two-phase regulatory and commercialization strategy to maximize the system's commercial opportunity while providing near-term value-inflection commercial milestones. In Phase 1, the company will commercialize Esocheck as a 510(k)-cleared cell collection device and EsoCheck Dx as a laboratory developed test. Lucid will then seek specific indication for widespread BE screening using EsoCheck using the American College of Gastroenterology guidelines.