Corgenix Medical Corp. (OTCBB: CONX) today announced it received 510(k) clearance from the U.S. Food and Drug Administration for its IgG Anti-AtherOx Test Kit used to detect antibodies in individuals with autoimmune diseases. Research data shows the association of antibodies to the AtherOx complex with vascular thrombosis in patients with autoimmune diseases. According to the press release, the clearance will allow for the new laboratory test to be marketed on a global scale.
“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,” Douglass Simpson, Corgenix’ president and CEO stated.
Studies regarding autoimmune disease and AtherOx were published in The Journal of Clinical and Developmental Immunology (2003) and The American Journal of Pathology (2004). Testing of the serum samples from lupus patients for a series of risk factors showed the measurement of the AtherOx antibody was significantly better than conventional anti-cardiolipid 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,” Luis Lopez, M.D., Corgenix’ Chief Medical Officer, stated. “It provides vital clinical information for physicians treating individuals with SLE and antiphospholipid syndrome, both of which are very important clinical problems.”
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