BALTIMORE—Previse, a gastrointestinal health company, announced recently that its clinical validation study results for its flagship assay, Esopredict, were published in the American Journal of Gastroenterology (AJG). The study, “Validation of an Epigenetic Prognostic Assay to Accurately Risk Stratify Patients with Barrett’s Esophagus,” highlights Esopredict, a first-in-class DNA methylation test for identifying patients with precancerous Barrett’s esophagus (BE) who are likely to progress to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in the future.
“Effective treatments are available for patients with Barrett’s esophagus,” said Sarah Laun, PhD, vice president of research and development. “However, gastroenterologists have lacked access to an epigenetic tool that identifies patients likely to progress towards cancer. Esopredict enables clinicians to identify high-risk patients earlier, allowing them to intervene and treat sooner, potentially saving patients’ lives.”
Esopredict is the first and only epigenetic assay to predict the likelihood of a person diagnosed with BE of progressing to HGD or EAC within five years. Esopredict analyzes DNA methylation levels, an early indicator of disease progression or cancer that often precedes morphologic changes. Each result includes a personalized risk score and a patient’s probability of progression.
The retrospective study included 240 patients whose esophageal biopsy samples were collected across six U.S. clinical sites, including Allegheny Health Network, Capital Digestive Health Specialists, Johns Hopkins University, Mayo Clinic, University of Connecticut, and University of Maryland. Patient samples were processed at Previse’s CLIA laboratory in Baltimore, Maryland. Each sample was analyzed to quantify DNA methylation levels using biomarkers that were integrated into a predictive algorithm to determine each patient’s likelihood of progressing to HGD or EAC within five years. The algorithm was locked and tested on an independent validation set.
Study results were remarkable in demonstrating that patients identified by Esopredict as high risk had an average risk of progression of 22% within five years, 4 times more likely than the average risk based on prevalence to progress to HGD or EAC, while low-risk patients reflected only a 1.9% risk, with a modeled negative predictive value of 99%.
“This study represents a major leap forward for the care of patients diagnosed with Barrett’s esophagus,” said senior author and Previse cofounder and advisor, Dr. Stephen J. Meltzer. “This study represents that for the first time, we can offer gastroenterologists a precise, quantitative and tailored approach to personalize surveillance and treatment management decisions.”
According to Previse, Esopredict is exceptional among molecular diagnostics innovations, as it is uniquely designed to focus on epigenetic biomarkers: chemical changes to a patient’s DNA that control gene expression. Such DNA methylation alterations often occur early, before neoplastic changes emerge. By quantitatively measuring these changes and stratifying patient risk, Esopredict complements traditional BE management by allowing gastroenterologists to use esophageal biopsy tissue that is routinely collected during a patient’s surveillance endoscopy, including archived tissue.
“We are excited about Esopredict’s timing and ability to change the paradigm in BE surveillance and treatment,” said Daniel Lunz, chief executive officer and cofounder of Previse, “as esophageal cancer rates have continued to climb and claim more lives each year.”
