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Lucid Diagnostics Inc., a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc., announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application covering its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to help detect esophageal precancer and cancer, a key component of its EsoGuard Esophageal DNA Test.
"This patent strengthens the already robust intellectual property portfolio underlying our groundbreaking technologies and will provide strong protection for the CCNA1 methylation assay method which is at the heart of the EsoGuard assay," said Lishan Aklog, M.D., Lucid's chairman and chief executive officer. "The allowance validates our strategy of focusing on the laboratory methods of our assay—a strategy we will continue to aggressively pursue for other components of the assay."
EsoGuard utilizes next-generation sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1). Such methylation has been shown to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett's Esophagus or BE), to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma). Although VIM methylation had been previously associated with gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific.
The technology behind EsoGuard and the EsoCheck Esophageal Cell Collection Device was developed at Case Western Reserve University (CWRU) by faculty members Sanford Markowitz, M.D., PhD, Amitabh Chak, M.D., and Joseph Willis, M.D., with the support of research funds from the National Institutes of Health (NIH) and elsewhere. Lucid holds the exclusive worldwide license to commercialize this technology. The successful transfer of the assay from the academic research laboratory and its subsequent commercialization was the result of close, ongoing collaboration between Lucid and CWRU.
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer.
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