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
- 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
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
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
“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