Summary: Lucid Diagnostics announced the peer-reviewed publication of an analytical validation study for its EsoGuard Esophageal DNA test, highlighting its performance in diagnosing esophageal precancer and adenocarcinoma.
Takeaways:
- The EsoGuard Esophageal DNA test demonstrated 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% precision in the study.
- The EsoGuard test utilizes next-generation sequencing (NGS) to detect DNA methylation in key genes associated with Barrett’s Esophagus and esophageal adenocarcinoma.
- The study reinforces EsoGuard’s clinical validity and utility, supporting its use in the early detection of esophageal precancer and cancer in a CLIA-certified, CAP-accredited, NY State-approved laboratory.
Lucid Diagnostics, a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc., announced the peer-reviewed publication of an analytical validation study of its EsoGuard Esophageal DNA test for the diagnosis of esophageal precancer (Barrett’s Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid’s EsoCheck Esophageal Cell Collection Device.
The manuscript, entitled “Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck, a Non-Endoscopic Esophageal Cell Collection Device”, has been published in the peer-reviewed journal Diagnostics, and is currently available via open access online.
“This analytical validation study strongly complements EsoGuard’s extensive peer-reviewed, published clinical validity and clinical utility evidence base,” says Suman Verma, MD, PhD, Lucid’s chief scientific officer. “The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory.”
The publication details comprehensive studies demonstrating excellent analytical performance of the EsoGuard assay on samples collected with EsoCheck, including 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% inter- and intra-assay precision. EsoGuard utilizes next-generation sequencing (NGS) to detect DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1), which have been shown to be associated with conditions along the BE-EAC spectrum.
Further reading: Lucid Diagnostics Esophageal Precancer Test Receives Positive Data in Clinical Validation Study
