The test uses esophageal samples collected using Lucid’s 510(k)-cleared EsoCheck cell collection device from certain patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). EsoGuard and EsoCheck are designed to facilitate the diagnosis of Barrett’s esophagus 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.
Although the American College of Gastroenterology (ACG) practice guidelines recommend screening in millions of high-risk patients to detect and treat Barrett’s esophagus, fewer than 10% actually undergo screening using the traditional invasive approach, upper endoscopy, according to PAVmed. Most patients diagnosed with EAC are either unaware of their underlying Barrett’s esophagus or of their missed opportunity to undergo treatment following an earlier diagnosis, the company added.
As a result, more than 80% die within five years of diagnosis. PAVmed estimated a minimum $2 billion immediately addressable domestic market opportunity for EsoGuard at at least $2 billion, based on clinical testing guidelines.
EsoGuard sequences bisulfite-converted DNA to detect methylation at 31 sites on two genes (VIM and CCNA1). It has been shown in a 408-patient human study published in Science Translational Medicine to be highly accurate at detecting BE, with and without dysplasia, as well as EAC, with greater than 90% sensitivity and specificity.
EsoGuard, which is already commercially available as a laboratory-developed test, is the subject of two Lucid-sponsored international multi-center IVD clinical trials in support of an FDA PMA. The screening study will enroll GERD patients without a prior diagnosis of Barrett’s esophagus or EAC who satisfy clinical screening guidelines. The case control study will enroll patients previously diagnosed with Barrett’s esophagus or EAC. In both studies, EsoGuard will be compared to the gold standard of endoscopy with biopsies. Both studies will begin enrolling patients in the coming weeks at 60 sites in the U.S. and Europe.
“EsoGuard’s FDA breakthrough device designation represents a major milestone for PAVmed and Lucid,” said Dr. Lishan Aklog, PAVmed’s chairman and CEO 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.”