FDA Clears Two New Autoimmune Assays for Celiac Disease

Gastroenterologists have two new options to aid in the diagnosis with Celiac disease, as the FDA gave 510(k) clearance to two new, CLIA Moderate Complexity, EliA autoimmune antibody assays from Phadia.

The assays, EliA GliadinDP IgA and EliA GliadinDP IgG (deamidated peptides), have proven to be essential, sensitive and specific markers to aid in the diagnosis of celiac disease.

Delayed diagnosis of celiac disease predisposes patients to increased morbidity and mortality, including cancer. The syndrome occurs due to an autoimmune reaction and more specifically, an inability to process gluten, a normally beneficial substance contained in wheat, barley and rye.

In the United States, 1 out of every 133 people has celiac disease. However, only 1 in 10 people with the disease are actually diagnosed. Of these, symptoms usually persist for years prior to a correct diagnosis. There may be as many as 2 million people in the US with celiac disease who do not even know it.

The EliA assays are available on the Phadia Laboratory Systems Phadia 100 and Phadia 250 and feature a quick turnaround time, are performed under master curves with monthly calibration, have on board instrument dilution capability, and are performed using a discrete, single well, random access, non-microtiter plate format.

Source: Phadia