Corgenix Medical Corporation (NASDAQ: CONX.OB) received 510(k) clearance by the FDA for their IgG Anti-AtherOx® Test Kit. This new laboratory test detects antibodies in individuals with important autoimmune diseases such as systemic lupus erythematosus and other and lupus-like disorders.
The AtherOx® technology utilizes oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein B2GPI. Although oxLDL has been implicated in cardiovascular disease, according to results published in the Annals of N.Y. Academy of Science (2007), determination of oxLDL/B2GPI complexes, rather than oxLDL alone, may be a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease in individuals with systemic lupus erythematosus and lupus-like disorders. Corgenix licensed this technology in 2002, and is developing additional products utilizing this unique platform. Two U.S. patents have been issued and several others are pending.
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