Diagnovus LLC, a molecular diagnostics company focused on underserved, aggressive, and lesser-known diseases, has entered into a licensing agreement with Cincinnati Children’s Hospital Medical Center to commercialize the first genomic assay to help physicians diagnose and treat eosinophilic esophagitis (EoE), a debilitating inflammatory condition.
The Engauge GI-EoE test is designed to improve the speed and accuracy of EoE diagnosis. The technology is based on research conducted at Cincinnati Children’s, an internationally recognized medical center for improving child health and transforming the delivery of healthcare through fully integrated, globally recognized research, education, and innovation.
EoE is an allergic inflammatory condition of the esophagus that affects patients of all ages, although it is most common in children and in adults under 50 years of age. Symptoms include difficulty eating, failure to thrive, vomiting, chest or abdominal pain, problems swallowing, and food impaction.
Until now, the only widely accepted means of diagnosing EoE has been based on histological analysis of esophageal biopsies, together with clinical symptoms. Often, five or more biopsies have been required. Unfortunately, the inflammation associated with esophageal eosinophilia is not specific to EoE, as it also occurs in other disease processes, including gastroesophageal reflux disease (GERD), infections, and autoimmune diseases, rendering histology-based diagnosis problematic.
Marc E Rothenberg, MD, PhD
The Engauge GI-EoE is a proprietary gene expression assay that accurately identifies EoE and differentiates it from GERD or chronic esophagitis. The assay uses RT-PCR technology to assess a panel of 96 genes obtained from formalin-fixed, paraffin-embedded biopsy material. Samples are analyzed at Diagnovus’s high complexity CLIA-certified laboratory.
The Engauge technology stems from research led by Marc E. Rothenberg, MD, PhD, director of the division of allergy and immunology and the center for eosinophilic disorders at Cincinnati Children’s.
Niki Robinson, PhD
“We are excited that Dr. Rothenberg’s research breakthroughs in the field of eosinophilic esophagitis are leading one step closer to changing the outcome for patients through our licensing agreement with Diagnovus,” said Niki Robinson, PhD, assistant vice president of the center for technology commercialization at Cincinnati Children’s.
“Diagnovus is committed to addressing the needs of patients with underserved diseases such as eosinophilic esophagitis,” said James Stover, PhD, president and co-founder of Diagnovus. “We are proud to collaborate with Cincinnati Children’s Hospital on this disease and believe the results from this partnership will help many children and adult patients battling this difficult illness.”
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 Diagnovus LLC.
