Background and Aims Barrett’s Esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). We aimed to assess performance, safety, and tolerability of the EsoGuard (EG) assay on samples collected non-endoscopically with the EsoCheck (EC) device (EG/EC) for BE detection in the intended-use population, meeting American College of Gastroenterology (ACG) guideline criteria (chronic gastroesophageal reflux disease (GERD) and 3+ additional risk factors).

Methods We performed a prospective, multicenter study (NCT04293458) to assess EG performance (primary endpoint) on cells collected with EC, for detection of BE and EAC using esophagogastroduodenoscopy (EGD) and biopsies as the comparator. Twenty-four sites across the U.S. and Spain participated. EC safety and usability were assessed as secondary endpoints.

Results 180 male subjects aged >50 years with chronic GERD met eligibility criteria, of which 163 (90.6%) had EGD and successful EC administration. Mean age was 60.5yrs, 34.4% were obese, 56.7% had tobacco history, and 3.9% had a 1st degree relative with BE or EAC. Of 122 samples analyzed, 93 contributed to the primary endpoint analysis. About 9% of subjects in the Primary Analysis Population had BE on EGD, none with dysplasia. Sensitivity of EG for BE was 87.5% (95% CI 47.4-99.7), specificity was 81.2% (95% CI 71.2-88.8), positive predictive value was 30.4% (95% CI 13.2-52.9), and negative predictive value was 98.6% (95% CI 92.3-99.96). Mild esophageal abrasions were observed in 1.5%; no serious adverse events were reported.

Conclusions EG/EC appears effective for BE screening. This approach provides a safe, accurate, and well-tolerated non-endoscopic alternative in high-risk patients.

NJS: Grant support - Lucid Diagnostics, Interpace Diagnostics, Phathom Pharmaceuticals, Medtronic, Steris, Pentax, and CDx Medical. Consultant - Exact Sciences, Phathom Pharmaceuticals, Cook Medical, Previse, and GIE Medical. MOO: Grant support - Lucid Diagnostics, AbbVie, Nestle, ConMed, Olympus and Boston Scientific; Consultant - Olympus, Boston Scientific Corporation, Abbvie, ConMed, Neptune Medical, Creo Medical, Lumendi, and Apollo. JT: No financial conflict of interest. KJC: Grant support: Lucid Diagnostics; Consultant: Cook Medical, EndoGastric Solutions, and Medtronic SJ: No financial conflict of interest. PSY: No financial conflict of interest. JCF: Consultant - Merit, Circa Scientific, and Aspero Medical. JSS: No financial conflict of interest. SV: Executive employee and shareholder - Lucid Diagnostics. VTL: Executive employee and shareholder - Lucid Diagnostics. BJD: Executive employee and shareholder - Lucid Diagnostics. LA: Executive employee, Board member, and shareholder - Lucid Diagnostics.

NCT04293458

This study was funded by Lucid Diagnostics Inc.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Central WCG IRB gave ethical approval for this work. Sponsor Pr. No.: PR-0139 (EG-CL-101) IRB Pr. No: 20200065

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All data produced in the present study are available upon reasonable request to the authors