Lucid Diagnostics, a cancer prevention diagnostics company and a subsidiary of PAVmed, has released new real-world data from its ENVET-BE study that supports the clinical utility of its EsoGuard Esophageal DNA test.
The EsoGuard test facilitates the detection of Barrett’s oesophagus and oesophageal adenocarcinoma through a simple office-based procedure, without the need for endoscopy.
It uses Targeted next-generation sequencing (NGS) to examine individual DNA molecules for cytosine methylation at 31 specific genomic locations.
ENVET-BE assessed patients who underwent invasive oesophagogastroduodenoscopy (EGD) after a positive EsoGuard test.
The data showed the efficacy of the EsoGuard Esophageal DNA test as a non-invasive triage tool.
It helped improve the positive yield of invasive upper endoscopy (EGD) for detecting oesophageal precancer and cancer.
According to the results, these patients experienced a 2.4-fold increase in positive yield compared to the anticipated yield from screening EGD alone in at-risk individuals.
In a real-world commercial setting, EGD confirmed Barrett’s Oesophagus in 50 out of 199 patients who underwent clinically directed EsoGuard testing and received a positive result.
This corresponds to a post-triage EGD yield of 25%, compared to the anticipated 11% yield when EGD is used alone as a screening tool in the at-risk population.
These results align with findings from a study that utilised EsoGuard for screening high-risk veterans.
Lucid Diagnostics chief medical officer Victoria Lee said: “The ENVET-BE study demonstrates that triaging at-risk patients with EsoGuard significantly increases the yield of EGD, which should lead to more efficient use of endoscopy resources while improving early detection of esophageal precancer.
“These results support published professional society guidelines which include non-endoscopic biomarker tests, such as EsoGuard, as an acceptable alternative to EGD for oesophageal precancer testing.
“Using EsoGuard to triage patients to EGD has the potential to increase compliance with oesophageal precancer screening guidelines and reduce oesophageal cancer deaths.”
In July, the cancer prevention diagnostics company announced positive findings from the ESOGUARD BE-1 study of its EsoGuard Esophageal Precancer Testing.
