Summary: Lucid Diagnostics has secured a patent allowance for its proprietary method of using CCNA1 gene methylation to detect esophageal precancer and cancer, strengthening the intellectual property behind its EsoGuard Esophageal DNA Test.

Takeaways:

  1. The new patent protects the CCNA1 methylation assay, a crucial component of Lucid’s EsoGuard test for detecting esophageal precancer and cancer.
  2. EsoGuard uses next-generation sequencing (NGS) to assess DNA methylation on 31 sites across two genes, offering a novel approach to diagnosing esophageal neoplasia.
  3. Lucid’s exclusive commercialization of this technology is the result of collaboration with Case Western Reserve University, supported by the NIH.

Lucid Diagnostics, a commercial-stage, cancer prevention medical diagnostics company, 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,” says Lishan Aklog, MD, Lucid’s chairman and CEO. “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.”

The Esophageal Cancer DNA Test

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, MD, PhD, Amitabh Chak, MD, and Joseph Willis, MD, 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.