Phadia's four new EliA autoimmune antibody assays receive FDA clearance

Jun 25 2010

Today Phadia announced that it has received FDA 510 (K) clearance for four new EliA autoimmune antibody assays. These new assays will provide physicians with additional tools needed to aid in the diagnosis of Antiphospholipid Syndrome (APS). The newly available EliA assays, anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM, have proven to be essential, sensitive, and specific markers to aid in the diagnosis of APS.

Antiphospholipid syndrome is a disorder of coagulation that causes thrombosis (blood clots) in both arteries and veins. The syndrome can affect any organ system and is a common cause of pregnancy related complications such as miscarriage, stillbirth, preterm delivery, or severe preeclampsia. The most common venous event is deep vein thrombosis of the lower extremities (blood clot of the deep veins of the legs), and the most common arterial event is stroke. In some cases, APS seems to be the leading cause of mental and/or development retardation in the newborn. The syndrome occurs due to an autoimmune reaction and production of antibodies against phospholipid (aPL), a normally beneficial cell membrane substance.

Autoimmune diseases impact an estimated 46 million patients per year in North America. These diseases pose a significant diagnostic challenge for clinicians. Antiphospholipid syndrome is complex and represents a common autoimmune diagnostic challenge. These four new EliA assays, when used together, represent the first and only fully automated diagnostic tests that can be utilized to aid in the accurate diagnosis of APS.

Gabi Gross, Autoimmune Franchise Leader of Phadia US, says, "Since its inception in 1967, Phadia has set the standard in the detection and diagnosis of allergies. Now, with the introduction of the EliA autoimmune product line in the United States, we are providing laboratories and clinicians with the same standard providing diagnostic tools with high performance assays to support the diagnosis of autoimmune diseases such as antiphospholipid syndrome."

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 Cyclic Citrullinated Peptide (CCP), tissue Transglutaminase (tTG) IgA and IgG (Celikey^®), Gliadin IgA and IgG, dsDNA, Extractable Antinuclear Antibody (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.