FDA calls New Screening Test Using DNA a Breakthrough Device
Lucid Diagnostics’ Esophageal DNA Test has received Breakthrough Device designation from the U.S. Food and Drug Administration. These early detection devices have the potential to save thousands of lives each year
Highlighted as one of the year’s significant advances in cancer prevention in the National Cancer Institute’s 2020 Annual Plan and Budget Proposal submitted to Congress. They are designed to facilitate the diagnosis of Barrett’s Esophagus (BE), with and without dysplasia – a progression of precursor conditions that culminate in highly lethal esophageal cancer (EAC) – as well as EAC itself, in patients with chronic heartburn, also known as gastroesophageal reflux disease (GERD).
Although the American College of Gastroenterology’s professional society practice guidelines recommend screening in millions of high-risk patients to detect and treat BE, with or without dysplasia, before it progresses to EAC, fewer than 10% actually undergo screening using the traditional invasive approach, upper endoscopy. Most patients diagnosed with EAC are neither aware of their underlying BE, nor that they missed the opportunity to undergo treatment which could have prevented progression to EAC had the BE been diagnosed earlier.
“EsoGuard’s FDA Breakthrough Device designation represents a major milestone,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive Chairman. “This designation validates our belief that EsoGuard is a groundbreaking technology that has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing deaths from cervical cancer. We look forward to working closely with the FDA to advance our EsoGuard in-vitro diagnostic (IVD) clinical development program at an expedited pace.”