FDA grants Phadia 510(k) clearance for CLIA Moderate Complexity, EliA autoimmune antibody assays

Today Phadia announced that it has received FDA 510(k) clearance for two new, CLIA Moderate Complexity, EliA autoimmune antibody assays. The new assays will provide physicians with additional tools needed to aid in the diagnosis of Celiac disease. The newly available assays, EliA Gliadin^DP IgA and EliA Gliadin^DP IgG (deamidated peptides), have proven to be essential, sensitive and specific markers to aid in the diagnosis of celiac disease.

Celiac disease is an autoimmune disorder that can cause severe gastrointestinal distress symptoms (diarrhea, bloating, constipation, nausea). The disease is often symptomatic but can remain undiagnosed for years. Delayed diagnosis 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.

Autoimmune diseases impact an estimated 46 million patients per year in North America. These diseases pose a significant diagnostic challenge for clinicians. Celiac disease is complex and represents a common autoimmune diagnostic challenge. Combining Gliadin^DP with the already approved tissue Transglutaminase (tTG) assays, provides a highly sensitive and specific simple tool to aid in the early diagnosis of celiac disease. The results help guide treatment and reduce the need for intestinal biopsies. Gabi Gross, Autoimmune Franchise Leader of Phadia US, says 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 level 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 endoscopies and biopsies."

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.

Diagnosis of celiac disease has never been easier and these extremely accurate blood tests can even be used to test people who present with atypical symptoms but are at risk for developing celiac disease.

The clearances announced today extend Phadia's product line of CLIA Moderately Complex assays in the EliA autoimmune product line. Other commercially-available EliA assays include Anti-Cardiolipin (aCL) IgG/IgM, Anti-B2-Glycoprotein 1 (anti-B2-GP1) IgG/IgM, Cyclic Citrullinated Peptide (CCP), tissue Transglutaminase (tTG) IgA/ IgG, Gliadin IgA/IgG, dsDNA, Antinuclear Antibody Screen (Symphony), and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP and Jo-1.

The EliA assays are available on the Phadia Laboratory Systems Phadia^® 100^Є 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.