On March 24, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center ("Cleveland VA") have enrolled their first patient in a Department of Defense ("DoD") funded study of its EsoGuard Esophageal DNA Test ("EsoGuard") in at-risk patients with gastroesophageal reflux disease ("GERD") (Press release, Lucid Diagnostics, MAR 24, 2022, View Source [SID1234610927]). Cleveland VA gastroenterologist Katarina B. Greer, M.D., Associate Professor of Medicine at Case Western Reserve University School of Medicine, is serving as the study’s principal investigator. Lucid is providing EsoCheck Esophageal Cell Collection Devices ("EsoCheck") for the study and will perform EsoGuard testing on the samples collected.
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"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer"
"We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test."
"Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer," said Dr. Greer. "We hope to demonstrate that a strategy which incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improve the yield of endoscopy and overall cost-effectiveness."
Traditional, invasive upper gastrointestinal endoscopy (EGD) is performed in less than 10% of at-risk GERD patients recommended for esophageal precancer (BE) screening. Of those who do undergo EGD screening, over 80% have a negative result, exposing the vast majority of these patients to a complex, invasive, costly, and inconvenient procedure requiring anesthesia at a specialized procedure center or hospital. EsoGuard performed on samples collected with EsoCheck, has been shown to be 90% sensitive and specific at detecting esophageal precancer and cancer with the potential to eliminate the majority of these negative EGDs delivering benefits to patients, providers, and the healthcare system.
The study will enroll up to 100 Cleveland VA patients who fulfil the American College of Gastroenterology criteria for esophageal precancer screening. The study compares two screening strategies: (1) EGD screening, the current standard of care; and (2) EsoGuard testing followed by EGD only in those with a positive EsoGuard result. The study will report whether using EsoGuard to triage patients to EGD will increase the overall BE screening rate and decrease the percentage of negative screening EGDs. The study will also estimate cost implications within the VA system between these two strategies.
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.
Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.
The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.
EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.