Lucid Diagnostics, a subsidiary of PAVmed, said that its LucidDx Labs has launched EsoGuard 2.0, the next generation EsoGuard Esophageal DNA test, for esophageal precancer detection.
The EsoGuard Esophageal DNA test is intended to help in preventing cancer and related death through early detection of esophageal precancer in patients who are at risk.
The next generation assay, which received the US Food and Drug Administration (FDA) breakthrough device designation in 2020, is said to have advanced molecular techniques and upgradation in sample DNA yields.
It has shown improved assay performance and lower costs in extensive validation studies, including head-to-head comparisons between multiplexed triplicate consensus and singleplex procedures.
LucidDx Labs will now use EsoGuard 2.0 to process all the commercial and research samples.
Lucid Diagnostics chairman and chief executive officer Lishan Aklog said: “The launch of EsoGuard 2.0 is a seminal milestone for our company and the culmination of over a year of meticulous R&D work by our Chief Scientific Officer, Suman Verma, M.D, Ph.D., and her dedicated and talented team.
“EsoGuard had previously demonstrated unprecedented cancer and precancer detection results, including detecting 100 percent of esophageal cancers and over 80 percent of precancers in a recent study from the National Cancer Institute-funded BETRNet consortium.
“EsoGuard 2.0 improves upon EsoGuard 1.0’s already outstanding performance in multiple respects, including by enhancing DNA yield, streamlining down-stream processes that incorporate advanced molecular techniques and more efficient bioinformatics, and enabling higher-throughput testing.”
The EsoGuard assay procedure includes the DNA extraction from esophageal cells collected by the EsoCheck Cell Collection Device, followed by bisulfite conversion of DNA.
The genes associated with esophageal precancer and cancer are amplified using polymerase chain reaction (PCR) procedures and subsequently analysed using next-generation sequencing (NGS) techniques.
According to Lucid Diagnostics, advanced bioinformatics software will assess the DNA sequence data and determine the percentage of the 31 target sites that are methylated. The outcome will be generated as a positive or negative EsoGuard result.
EsoGuard 2.0 makes use of multiplexing, which enables the examination of both genes on a single DNA sample.
As per the medical diagnostics company, the lab can use the assay to perform the test thrice and determine whether findings are positive or negative by consensus. This will help mitigate the impact of stochastic noise on low-positive samples that are close to the cutoff, Lucid Diagnostics added.
