Celiac Disease Is a Silent Killer- Phadia US Inc. to Launch Two New, Technologically-Advanced Diagnostic Tests

UPPSALA, SWEDEN--(Marketwire - October 08, 2009) - Phadia Inc., worldwide leaders in the development, manufacturing and marketing of complete blood test systems for the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases, today announced the launch of a two new, highly -reliable 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: 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 bright 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(DP) IgA and EliA™ Gliadin(DP) 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™ Gliadin(DP) IgA and EliA™ 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™ Gliadin(DP) IgA and EliA™ 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”.

About Phadia

Phadia develops, manufactures and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. Besides strategic management, administration and business development, the international centre in Uppsala incorporates extensive research and development facilities, a state-of-the-art production plant and distribution system operating cost-effectively around the clock. In Freiburg, Germany, a second centre develops and supports diagnostic tests for autoimmune diseases. Some 98% of production is exported to more than 3,000 laboratories in 60 countries. Supplying seven out of ten allergy laboratory tests worldwide, the company has remained the world leader in its field for more than 25 years.

Forward-looking statements

Except for historical information, all of the statements, expectations, and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Phadia attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based.