Phadia receives FDA 510 (k) clearance for EliA APS tests

Phadia is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for EliA Cardiolipin and EliA ß2-Glycoprotein I (both IgG and IgM) assays for the detection of autoantibodies to aid in the diagnosis of the Antiphospholipid Syndrome (APS).

The syndrome which can cause blood clots (thrombosis) in both, arteries and veins as well as pregnancy-related complications occurs due to the autoimmune production of several antibodies, especially antibodies against Cardiolipin and ß2-Glycoprotein I. Phadia blood tests successfully detect these autoantibodies. The submitted test performance data has been confirmed by the American FDA Authority.

EliA Cardiolipin and EliA ß2-Glycoprotein I assays will now also be available in the U.S.

For any further information please feel free to contact Phadia US Inc.

Phadia Customer Service: +1 800 346 4364 (Toll-free)

6/16/2010

 

As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.