Diagnovus LLC, Nashville, Tenn, a molecular diagnostic company focused on underserved, aggressive, and lesser-known diseases, introduces the ENGAUGE™ GI – Barrett’s Esophagus, which it describes as the first commercially available genomic assay to aid physicians in predicting the risk of progression to high-grade dysplasia or esophageal adenocarcinoma (EAC) in Barrett’s Esophagus patients.
It is a proprietary gene expression assay for patients with Barrett’s Esophagus 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.
“At Diagnovus, our goal in launching the ENGAUGE™ GI – Barrett’s Esophagus assay is to provide physicians with a unique and adjunctive assessment of a Barrett’s Esophagus patient’s risk of progressing,” says James Stover, PhD, vice president and co-founder. “With this addition to their current standard of care, physicians now have the ability to better identify progressor and nonprogressor patients, and then tailor surveillance frequency specific to each patient.”
|Barrett’s Esophagus is characterized by cellular change in the epithelial lining of the esophagus. The resulting cellular change is a premalignant phase that may lead to esophageal adenocarcinoma, thus placing Barrett’s Esophagus patients at higher risk of esophageal cancer.|
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 lab.
Patients with Barrett’s Esophagus are at higher risk than the general population 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.
The assay was developed by Steven J. Meltzer, MD, professor of medicine and oncology and director of the GI Early Detection Biomarkers Laboratory at Johns Hopkins University School of Medicine. The technology was made available for licensing from Johns Hopkins University through an agreement with MPEG LA.®