DENVER, April 10 /PRNewswire-FirstCall/ -- Corgenix Medical Corporation (OTC Bulletin Board: CONX) announced receipt of 510(k) clearance by the United States Food and Drug Administration (FDA) for the Company's IgG Anti-AtherOx(R) Test Kit. This new laboratory test, now available worldwide, utilizes the Company's patented AtherOx(R) 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 (R) 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(R) 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(R) is another significant step forward in this important clinical market."
The IgG Anti-AtherOx(R) Test Kit is CE marked for use in the European Union. The Company will market the new product worldwide through its existing distribution network.
The AtherOx(R) 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.
The IgG Anti-AtherOx(R) Test Kit indication for use is for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with B2-glycoprotein I (B2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 52 diagnostic products through a global distribution network. More information is available at http://www.corgenix.com.
Statements in this press release that are not strictly historical facts are "forward-looking" statements (identified by the words "believe", "estimate", "project", "expect" or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company's products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.
SOURCE Corgenix Medical Corporation