NEW YORK - Lucid (NASDAQ:LCID) Diagnostics Inc. (NASDAQ:LUCD), a cancer prevention medical diagnostics company, has released data from a clinical validation study that indicates its EsoGuard Esophageal DNA test has a high sensitivity for detecting esophageal precancer.
The study, conducted at the Louis Stokes Cleveland Veterans Affairs Medical Center, showed a sensitivity of 92.9% and a negative predictive value of 98.6% when compared to upper gastrointestinal endoscopy, a standard diagnostic procedure.
The study involved 128 eligible patients who had never undergone an upper gastrointestinal endoscopy but met the American College of Gastroenterology guidelines for esophageal precancer screening.
Out of these, 124 patients underwent non-endoscopic esophageal cell sampling with EsoCheck Cell Collection Device, followed by endoscopic examination. Biopsies confirmed twelve cases of esophageal precancer and two of esophageal cancer, establishing an overall disease prevalence of 12.9% in the sample population.
While the specificity of the EsoGuard test was 72.2%, lower than in previous studies, the positive predictive value of 32.5% was maintained, leading to a 2.5-fold increase in the positive yield of endoscopy procedures.
The authors of the study highlighted the potential of EsoGuard as a screening tool that could lead to improved prognosis for esophageal cancer by offering access to minimally invasive testing.
Dr. Victoria T. Lee, Lucid's Chief Medical Officer, emphasized the importance of this study, stating it supports the use of EsoGuard as a widespread screening tool. She also mentioned that three published clinical utility studies have shown near-perfect agreement between EsoGuard results and physician referral for endoscopy, suggesting that the test could lead to more cost-effective utilization of endoscopy for esophageal precancer detection.
This validation study adds to the body of evidence that supports the clinical effectiveness of EsoGuard and its potential role in esophageal cancer prevention. Lucid Diagnostics, a subsidiary of PAVmed Inc . (NASDAQ:PAVM), aims to prevent cancer deaths through early detection of esophageal precancer in patients at risk due to chronic heartburn or gastroesophageal reflux disease (GERD).
The data presented is based on a press release statement and has not yet undergone peer review. The study manuscript is available on the health sciences preprint server, medRxiv.
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