NEW YORK (GenomeWeb) – Molecular diagnostics firm Diagnovus announced today a licensing agreement with Cincinnati Children's Hospital Medical Center to commercialize a gene expression assay for the diagnosis of eosinophilic esophagitis (EoE).
The Engauge GI-EoE test, developed by researchers at the hospital, is the first genomic assay for diagnosing and treating EoE, Diagnovus said, adding it differentiates the ailment from gastroesophageal reflux disease (GERD) or chronic esophagitis.
EoE is an allergic inflammatory condition of the esophagus that occurs mainly in children, as well as adults under the age of 50. Histological analysis of esophageal biopsies and the evaluation of clinical symptoms have been the primary method of diagnosing the disease, but in addition to often requiring five or more biopsies for a diagnosis, esophageal eosinophilia is not specific to EoE as the condition can also occur in other disease processes, such as GERD, infections, and autoimmune diseases "rendering histology-based diagnosis problematic," Diagnovus said.
Engauge GI-EoE uses RT-PCR to assess 96 genes from formalin-fixed, paraffin-embedded biopsy material to accurately and rapidly diagnose EoE, the Nashville, Tenn.-based firm said. Samples are processed at Diagnovus' CLIA-certified laboratory.
Financial and other terms of its agreement with Cincinnati Children's Hospital Medical Center were not disclosed.