Diagnovus launches gene expression assay for patients with Barrett's esophagus

Oct. 10, 2013

Diagnovus, LLC, a molecular diagnostics company focused on underserved, aggressive, and lesser-known diseases, has announced the launch of the ENGAUGE GI – Barrett’s Esophagus, a genomic assay to aid physicians in predicting the risk of progression to high-grade dysplasia or esophageal adenocarcinoma (EAC) in Barrett’s esophagus patients. The assay will be introduced at the American College of Gastroenterology meeting in San Diego next week.

ENGAUGE GI – Barrett’s esophagus is a proprietary gene expression assay that uses RT-PCR to determine the methylation profile of a panel of eight genes. Methylation, a signaling tool that cells use to alter gene expression, is common in cancer development and may play a role in the carcinogenic process. An addition to Diagnovus’ ENGAUGE product portfolio, the assay uses routine biopsy material taken during endoscopic surveillance and can be performed in a highly reproducible and accurate manner using formalin-fixed, paraffin embedded (FFPE) diagnostic biopsy tissue. All samples are analyzed at Diagnovus’ high complexity CLIA-certified laboratory.

Patients with Barrett’s esophagus are at increased risk for developing EAC, a type of esophageal cancer. The current standard of care for patients with Barrett’s esophagus and low-grade dysplasia includes treatment for gastroesophageal reflux disease (GERD) and endoscopic surveillance to detect progression to high-grade dysplasia or EAC. Surveillance frequency and ablation therapy for higher-risk patients are controversial and depend on the stage of the disease.

With this assay, says James Stover, PhD, vice president and co-founder of Diagnovus, “physicians will have the ability to better identify progressor and non-progressor patients, and then tailor surveillance frequency specific to each patient.” Learn more about this tool for predicting esophageal cancer.