EoGenius™ Test for Eosinophilic Esophagitis Launched by Miraca Life Sciences

Inform Diagnostics, the nation’s largest independent anatomic pathology lab, has launched the EoGenius™ test which helps diagnose and monitor patients with eosinophilic esophagitis (EoE). Exclusively offered by Inform Diagnostics, the test helps clinicians differentiate between eosinophilic esophagitis and other clinical and pathologic mimics, such as GERD.

Details of the EoGenius test

  • The EoGenius test helps diagnose and monitor eosinophilic esophagitis
  • The assay panel comprises a 96-gene quantitative polymerase chain reaction array and an associated dual algorithm that uses cluster analysis and dimensionality reduction
  • Biopsy tissue from proximal, middle, or distal locations of the esophagus may be used
  • Formalin-fixed, paraffin-embedded tissue or RNA-later-preserved tissue may be used from a single biopsy
  • EoGenius has been validated in both adult and pediatric populations
  • The EoGenius report provides a result of Positive, Negative, or Indeterminate (approximately 10%), based on the gene expression score produced by the EoGenius algorithm

The EoGenius test was developed by Marc E. Rothenberg, MD, PhD, at Cincinnati Children’s Hospital using a cohort of pediatric patients. Previously, the test was commercially available from Diagnovus under the name Engauge. A recent independent study led by Evan Dellon, MD, MPH, of University of North Carolina School of Medicine, confirmed the utility of EoGenius in a large cohort of adult patients. The study will have a poster presentation at the AGA’s upcoming Digestive Disease Week conference.

Why is the EoGenius test important?
In clinical practice, differentiation is difficult between eosinophilic esophagitis and other common causes of esophageal eosinophilia, such as GERD, and other causes of dysphagia. Patients may have a mismatch between symptoms and histopathologic features, which creates a need for multiple assessments.

A study by Alain M. Schoepfer, MD, et al published in Gastroenterology found that patients with EoE had a median diagnostic delay of six years. Earlier, appropriate treatment can improve quality of life and prevent complications, including poor growth, nutritional deficiencies, food impaction, stricture formation, and spontaneous esophageal perforation, according to a study published in Best Practice & Research Clinical Gastroenterology by allergist Jonathan Spergel, MD, PhD.

Frank Basile, MBBS, president and CEO of Inform Diagnostics, stated: “Inform Diagnostics is committed to offering clinicians innovative and valuable decision-support tools to enhance patient care in GI disease. EoGenius will cast light on a condition that has been identified only in the past two decades, but is now considered a major cause of digestive system illness.”

“Validating the EoGenius test in a large population of adult patients represents a breakthrough for diagnosing eosinophilic esophagitis,” added Richard Lash, MD, Chief Medical Officer of Inform Diagnostics. “I have been impressed with the performance of the EoGenius test and the clarity it can provide to clinicians, now for both adult and pediatric patients. As we emphasize at Inform Diagnostics, every patient deserves the right answer.”

What is eosinophilic esophagitis?
Eosinophilic esophagitis is a chronic disorder of the esophagus thought to result from an immune reaction to various ingested and airborne substances. The diagnosis of EoE is based on clinical presentation, endoscopic appearance, and microscopic findings on biopsy of the esophageal mucosa. In adults, common symptoms of eosinophilic esophagitis include dysphagia (difficulty swallowing), food impaction, gastric reflux/GERD (heartburn), and abdominal pain. Children may experience vomiting, difficulty swallowing, and abdominal pain. Parents and other caregivers of infants may report difficulty feeding and failure of the child to gain weight, also known as “failure to thrive.”

Some of the GI pathologists at Inform Diagnostics, including Robert Genta, MD, Richard Lash, MD, Guy Lindberg, MD, Hossein Saboorian, MD, and Saime Aksoy, MD, have published several clinical research studies on EoE, which have contributed to the medical community’s understanding of this relatively new disease.

About Inform Diagnostics
Inform Diagnostics provides the highest quality anatomic pathology services, primarily in the fields of dermatology, hematology, gastroenterology, urology, and breast health. The company’s team of more than 90 distinguished expert subspecialists utilizes state-of-the-art pathology laboratories to serve more than 5,500 patients every day. Inform Diagnostics continuously improves diagnostic precision through consensus-based terminology and criteria, rigorous quality assurance, daily consensus conferences, extensive educational and training activities, and close relationships with clinical partners. Headquartered in Irving, Texas, Inform Diagnostics Life Sciences is a subsidiary of Inform Diagnostics Holdings Inc., Japan’s largest clinical diagnostics and laboratory testing service provider. For more information, visit www.MiracaLifeSciences.com.

Media contact information:
Joy Jennings, Director of Marketing

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