Phadia launches two diagnostic tests for celiac disease

9 October 2009

Phadia Inc., developer of blood test systems for allergy, asthma and autoimmune diseases, has announced the launch of two, assays to support the accurate diagnosis of celiac disease.

A watershed Mayo Clinic study published in last month's issue of Gastroenterology reports that celiac disease is four times more common today than it was 50 years ago. Another key finding is that individuals who don't realize they suffer from celiac disease (and therefore never received treatment for it) were four times more likely to have died during the study's 45 years of monitoring versus individuals not affected by celiac disease.

The study shines a light on the increasing prevalence of celiac disease, as well as its significant impact on mortality, and suggests that celiac disease could be a major public health issue.

Dr Stefan Eschbach, General Manager of Autoimmunity at Phadia, has said that these innovative, highly-accurate tests were developed in response to widespread demand from the healthcare community: "Physicians have been asking us for state-of-the-art assays with a high value of sensitivity and specificity. Our launch this month of EliA Gliadin IgA and EliA Gliadin IgG will offer physicians who suspect a possible case of celiac disease, antibody tests with the lowest number of false positive results. This means avoiding putting patients through unnecessary biopsies."

Diagnosis of celiac disease has never been easier and these blood tests can even be used to test people who may be at risk for having celiac disease, but have no symptoms.

Approximately 1 out of every 250 people may have celiac disease, however only 1 out of 10 people with the disease may be actually be diagnosed. There may be as many 3-5 million worldwide with celiac disease - most of whom do not even know it.

Celiac disease is a life-long condition in which ingestion of "gluten", the water insoluble wheat-gliadin and the prolamins in rye and barley, leads to chronic inflammation and damage of the mucosa (or lining) of the small intestine.

The disease is multifaceted in nature, and patients present to physicians with a varied array of symptoms and forms of the disease. Due to this clinically difficult differential diagnosis, only a relatively small proportion of patients are diagnosed in their childhood.

A specific fraction of gluten polypeptides, the "gliadins", are solely responsible for the toxic effects to the intestinal mucosa. Since the levels of both gliadin and tissue transglutaminase IgA antibodies correlate well with the morphological appearance of the small-intestinal mucosa, Phadia's non-invasive serological diagnosis of celiac disease is expected to increasingly replace the biopsy procedure, especially in children.

IgG antibodies to gliadin are less specific for celiac disease but are helpful markers in patients with IgA deficiency. Both types of gliadin antibodies are of particular importance for a diagnosis of celiac disease in children below the age of two. With EliA(TM) Gliadin(DP) IgA and EliA(TM) Gliadin(DP) IgG, Phadia is able to offer healthcare professionals two reliable, state of the art assays to support the accurate diagnosis of celiac disease, even among the very young.

Says Dr Stefan Eschbach, General Manager of Autoimmunity at Phadia, "This month's launch of EliA(TM) Gliadin(DP) IgA and EliA(TM) Gliadin(DP) IgG, coupled with our on-going efforts at the forefront of clinical diagnosis of celiac disease, demonstrate Phadia's unwavering commitment to this disease area, to improving quality of life for celiac disease patients and their families, and to always striving to meet the needs of the healthcare community who place their trust in us".

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