PAVmed Inc., a differentiated, multiproduct medical device company, announced that the company’s majority owned subsidiary, Lucid Diagnostics Inc. has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard Esophageal DNA Test on esophageal samples collected using its EsoCheck Cell Collection Device in a prevalent well-defined group of patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD).
 
“EsoGuard’s FDA Breakthrough Device designation represents a major milestone for PAVmed and Lucid,” said Lishan Aklog, M.D., 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.”
 
The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions” by expediting their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection balance. Breakthrough Devices receive priority FDA review, and a bipartisan bill before Congress (H.R. 5333) seeks to require Medicare to temporarily cover all Breakthrough Devices for three years while determining permanent coverage.
 
”I have dedicated my career to the care of patients across the disease spectrum from BE, with and without dysplasia, to lethal esophageal cancer, and have participated in some of the key developments in this field,” said Nicholas J. Shaheen M.D., MPH, professor of Medicine and Epidemiology and chief of the Division of Gastroenterology and Hepatology at UNC HealthCare, Director of the American College of Gastroenterology (ACG) Institute for Clinical Research and Education and lead author of its guidelines on the Diagnosis and Management of Barrett’s Esophagus. “I am very excited that the FDA deemed EsoGuard worthy of Breakthrough Device designation. This recognition significantly enhances EsoGuard’s potential to prevent deaths from esophageal cancer through early detection of these conditions.”
 
“I am very gratified that FDA agreed with us that EsoGuard satisfies all of its criteria for Breakthrough Device designation for the proposed indications for use,” said Alberto Gutierrez, Ph.D., Lucid’s regulatory consultant and former director of the FDA's Office of In-Vitro Diagnostics (OIVD). “I have participated in the designation of several IVD Breakthrough Devices and understand the value this brings to Lucid’s clinical development program. I look forward to continuing to work with Lucid and FDA as we take advantage of the enhanced and accelerated FDA engagement opportunities granted to Breakthrough Devices.”
 
The EsoGuard Esophageal DNA Test is performed on esophageal samples that are collected using Lucid’s FDA 510(k)-cleared EsoCheck Esophageal Cell Collection Device. These technologies were 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 heart burn, also known as gastroesophageal reflux disease (GERD).
 
Although the ACG’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 percent 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.
 
As a result, over 80 percent die within five years of diagnosis. The estimated immediately addressable domestic market opportunity for EsoGuard is at least $2 billion based on very modest penetration of the United States GERD patients currently recommended for BE screening according to ACG guidelines.
 
EsoGuard performs next generation sequencing (NGS) of bisulfite-converted DNA to detect methylation at 31 sites on two genes (VIM and CCNA1). EsoGuard 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 percent sensitivity and specificity.
 
EsoGuard, which is already commercially available as a Laboratory Developed Test (LDT), 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 BE or EAC who satisfy ACG BE screening guidelines. The case control study will enroll patients with a previous diagnosis of non-dysplastic BE, dysplastic BE (both low and high-grade) or EAC. In both studies, EsoGuard will be compared to the gold standard of endoscopy with biopsies. Dr. Shaheen serves as lead investigator for both studies, which will begin enrolling patients in the coming weeks at 60 sites in the United States and Europe.