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Diagnovus Launches First Gene Expression Assay for Patients With Barrett's Esophagus



10/8/2013 10:32:22 AM

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Diagnovus Launches First Gene Expression Assay for Patients with Barrett’s Esophagus

NASHVILLE, Tenn.--(BUSINESS WIRE)--Diagnovus, LLC, a molecular diagnostic company focused on underserved, aggressive and lesser-known diseases, today announced the launch of the ENGAUGE™ GI – Barrett’s Esophagus, 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. The assay is being introduced at the American College of Gastroenterology meeting in San Diego Oct. 11–16, 2013.

ENGAUGE™ GI – Barrett’s Esophagus 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 8 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 important addition to Diagnovus’ ENGAUGE™ product portfolio, the ENGAUGE™ GI – Barrett’s Esophagus 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 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 ENGAUGE™ GI – Barrett’s Esophagus assay was developed by Dr. Steven J. Meltzer, 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®.

“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,” said James Stover, Ph.D., vice president and co-founder of Diagnovus. “With this addition to their current standard of care, physicians now have the ability to better identify progressor and non-progressor patients, and then tailor surveillance frequency specific to each patient.”

About Barrett’s Esophagus

Barrett’s Esophagus is characterized by cellular change in the epithelial lining of the esophagus. The resulting cellular change is a pre-malignant phase that may lead to esophageal adenocarcinoma, thus placing Barrett’s Esophagus patients at higher risk of esophageal cancer. While the cause of Barrett’s Esophagus is unclear, it may result from damage to the esophagus caused by GERD. In addition to GERD, other risk factors for Barrett’s Esophagus include age (>50), ethnicity (Caucasian) and male sex. Treatment for GERD and endoscopic biopsies to screen for high-grade dysplasia or EAC are recommended for patients with Barrett’s Esophagus.

About Diagnovus

Founded in 2011 and based in Nashville, Tenn., Diagnovus is a specialized molecular diagnostic company focused on delivering personalized information and services to physicians treating patients suffering from underserved, aggressive and lesser-known diseases. Its mission is to improve the health of patients and quality of treatment decisions through innovative molecular diagnostics that better inform physicians, patients and their families facing these difficult disease prospects. Its core principles are defined by a commitment to bringing personalized genomics that will assist physicians in achieving better outcomes for their patients and contribute to a more efficient use of healthcare resources. Learn more at www.diagnovus.com.

Contacts

Diagnovus

James Stover, Ph.D.

855-642-8438

james.stover@diagnovus.com

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