FDA Clears IgG Anti-AtherOx Test Kit
Corgenix Medical Corporation announced receipt of 510(k) clearance by FDA for the Company's IgG Anti-AtherOx Test Kit. This new laboratory test, now available worldwide, utilizes the Company's patented AtherOx technology to detect antibodies in individuals with important autoimmune diseases.
Research data presented at several medical and scientific meetings has shown the association of antibodies to the AtherOx complex with vascular thrombosis (particularly arterial thrombosis) in patients with autoimmune diseases. Studies published in The Journal of Clinical and Developmental Immunology (2003) and The American Journal of Pathology (2004) showed that by testing serum samples from lupus patients for a series of risk factors, it was concluded the measurement of the AtherOx antibody was significantly better than conventional anti-cardiolipin testing in identifying patients with vascular complications, and illustrated a pivotal role of B2-glycoprotein I (B2GPI) in vascular injury and thrombosis.
"This test will be an important addition to our other phospholipid products currently used worldwide by physicians to identify patients with thrombosis-associated antibodies," said Luis Lopez, M.D., Corgenix' Chief Medical Officer. "It provides vital clinical information for physicians treating individuals with SLE and antiphospholipid syndrome, both of which are very important clinical problems."
Douglass Simpson, Corgenix' President and Chief Executive Officer said, "We are pleased to receive FDA clearance for this important product. Corgenix has a long history of developing and bringing to market innovative products for rheumatology and thrombosis-associated diseases, and our new IgG Anti-AtherOx is another significant step forward in this important clinical market."