FDA tells Phadia new tests can go on the market

Portage-based Phadia, which specializes in developing tests for allergies, has received FDA permission to market four new autoimmune antibody assays, procedures used to diagnose antiphospholipid syndrome.

Antiphospholipid syndrome causes blood clots in both arteries and veins.

The coagulation disorder can affect any organ system and is a common cause of pregnancy related complications such as miscarriage, stillbirth, preterm delivery, or severe preeclampsia.

The disorder is most commonly seen as a blood clot of the deep veins of the legs. In arteries it leads to stroke.

The syndrome occurs due to an autoimmune reaction and production of antibodies against phospholipid, a normally beneficial cell membrane substance. 

Autoimmune disease is the generic term for a number of clinical conditions in which antibodies, generated by the patient’s immune system, attack the body’s own cells and tissues.

Like other autoimmune diseases, antiphospholipid syndrome is complex and represents a diagnostic challenge for clinicians. The four new assays when used together are the only fully automated diagnostic tests that can be used to accurately diagnose antiphospholipid syndrome, says Gabi Gross, Autoimmune Franchise Leader of Phadia US.

Introduction of this product line provides laboratories and clinicians with the same high performance diagnostic tools as those the company provides for detection and diagnosis of allergies, Gross says.

Phadia US is a leader in research and development of blood testing products and instrumentation to aid in the accurate diagnosis of allergy.

Writer: Kathy Jennings
Source: Gabi Gross, Phadia US