Molecular diagnostics company Diagnovus has entered an agreement to validate a molecular test for eosinophilic esophagitis (EoE) and potentially license the test from developer Cincinnati Children's Hospital Medical Center.
EoE, also called inflammatory esophagitis, is diagnosed by the presence of white blood cell-containing infiltrate and a corrugated appearance in the esophagus. The disorder occurs in both adults and children, and is thought to be caused primarily by food allergies.
Correct diagnosis is especially important to guiding treatment in children, who may languish with symptoms that resemble gastroesophageal reflux but do not respond to typical anti-reflux medications.
The EoE assay was developed from a set of esophageal biopsy samples from children diagnosed with EoE and some children without the condition, yielding a 96-gene array measuring expression levels of many inflammation-related genes. The assay used low-density TaqMan qPCR arrays from Life Technologies.
A study validating the array was recently published in the journal Gastroenterology. In that paper, the assay was vetted against a collection of 194 samples of mixed diagnosis, including patients in remission from EoE. The assay identified adult and pediatric EoE patients with 96 percent sensitivity and 98 percent specificity, and could discriminate patients in remission from those with normal esophagi. The test could also be run using FFPE-derived RNA, the authors noted.
An accompanying editorial noted that the paper's findings "provide proof of principle for the use of a tissue-based molecular test in the diagnosis of EoE and highlight the advantages of such techniques over histologic analysis."
Cincinnati Children's has filed for several patents on the technology, one of which has been issued. Diagnovus, based in Nashville, Tenn., has entered into an option agreement with Cincinnati Children's for the assay.
Diagnovus recently announced the launch of an eight-gene, real-time PCR array test for Barrett's Esophagus, expanding on its growing line of personalized diagnostics for rare and orphan diseases.