Lucid Diagnostics, a medical diagnostics company specializing in cancer prevention, has announced the launch of the next generation of its EsoGuard Esophageal DNA test. This advanced test is designed for the detection of esophageal precancer and has shown improved assay performance and reduced costs in validation studies.
The EsoGuard 2.0 assay, now used for all commercial and research samples at LucidDx Labs, represents a significant advancement over the previous version. Dr. Lishan Aklog, Lucid’s Chairman & CEO, highlighted the meticulous R&D work led by Chief Scientific Officer Suman Verma, MD, PhD, and her team in developing EsoGuard 2.0. The original EsoGuard had already demonstrated remarkable cancer and precancer detection rates, including 100% detection of esophageal cancers and over 80% of precancers in a study by the National Cancer Institute-funded BETRNet consortium.
EsoGuard 2.0 enhances DNA yield, incorporates advanced molecular techniques and more efficient bioinformatics, and enables higher-throughput testing. These improvements also lead to lower per-sample costs, with further reductions expected as the company upgrades its NGS-sequencing platform.
The EsoGuard assay involves extracting DNA from esophageal cells collected by the EsoCheck Cell Collection Device, followed by bisulfite conversion, PCR amplification of two genes (VIM and CCNA1), and next-generation sequencing. Advanced bioinformatics software then analyzes the DNA sequence data. The new version of the assay uses a multiplexing technique, allowing both genes to be interrogated on a single DNA sample, enhancing the assay’s accuracy and efficiency.
The analytical and clinical validation studies of EsoGuard 2.0, including head-to-head comparisons of multiplexed triplicate consensus versus singleplex techniques, have been accepted for presentation at the upcoming Association of Molecular Pathology Annual Meeting (AMP 2023). The clinical validation analysis, including samples from the ESOGUARD-BE-1 study, demonstrated improved sensitivity and specificity of the next-generation assay.
This launch marks a significant milestone in esophageal cancer prevention and diagnostics, offering a more efficient and cost-effective method for early detection of precancerous conditions.