Pavmed subsidiary Lucid Diagnostics has introduced the next generation of the EsoGuard Esophageal DNA test (EsoGuard 2.0) to detect oesophagal precancer.
The company’s CAP-accredited, CLIA-certified laboratory LucidDx Labs will provide the new test and handle the processing of all commercial and research samples using the test.
The assay will extract DNA from oesophageal cells that are gathered using the EsoCheckcell collection device.
Later, the DNA is subjected to bisulfite conversion, marking sites that lack methylation.
Two genes, VIM and CCNA1, containing 31 methylation sites that correlate with oesophageal precancer and cancer, are amplified through polymerase chain reaction (PCR) methods and subsequently sequenced using next-generation sequencing (NGS) techniques.
Advanced bioinformatics software studies the DNA sequence data, identifying the proportion of the 31 target sites that are methylated. It provides either a positive or negative EsoGuard result.
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EsoGuard 2.0 utilises multiplexing, which enables both genes to be interrogated on one DNA sample.
The original assay deployed a singleplex method, requiring the division and independent processing of DNA for each gene.
This breakthrough enables the lab to conduct the assay three times, determining positive and negative results.
Furthermore, the new assay went through thorough validation studies, both analytically and clinically. This included direct comparisons between multiplexed triplicate consensus and singleplex techniques.
Clinical validation analysis used samples from the ESOGUARD-BE-1 study and showed enhanced specificity and sensitivity.
Lucid chairman and CEO Lishan Aklog said: “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.”