Healthcare Industry News: low-density lipoprotein
News Release - July 30, 2007
Corgenix Submits 510(k) Filing for IgG Anti-AtherOx(TM) Test Kit
Next-Generation Test Latest Addition to Portfolio of Company Antiphospholipid ProductsDENVER--(HSMN NewsFeed)--Corgenix Medical Corporation (OTCBB: CONX ) has submitted a 510(k) Premarket Notification to the United States Food and Drug Administration (FDA) for the Company's IgG Anti-AtherOx(TM) Test Kit. This new laboratory test utilizes the Company's patented AtherOx technology to detect IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with beta2-glycoprotein I (beta2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
Recently published research data shows the association of antibodies to the AtherOx complex with vascular thrombosis (particularly arterial thrombosis) in patients with autoimmune diseases. Results of the study were published at the Congress of the International Society on Thrombosis and Hemostasis (ISTH) in Geneva, Switzerland earlier this month. By testing serum samples from 113 SLE patients for a series of risk factors, it was concluded the measurement of AtherOx antibody was significantly better than conventional anti-cardiolipin testing in identifying patients with vascular complications, and illustrates a pivotal role of beta2GPI in vascular injury and thrombosis.
"This product will be an important addition to our other phospholipid products used worldwide by physicians to identify patients with thrombosis-associated antibodies," said Luis Lopez, MD, Corgenix' Chief Medical Officer.
Douglass Simpson, Corgenix' President and Chief Executive Officer, said, "We are pleased to submit the application 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 product is another significant step forward in this important clinical market."
About AtherOx(TM)
The AtherOx technology utilizes oxidized low-density-lipoprotein (oxLDL) complexed with the plasma protein beta2GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of oxLDL/beta2GPI complexes (AtherOx), rather than oxLDL alone, is a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease. 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.
Products using the AtherOx technology have not been cleared by the U.S. Food and Drug Administration for in vitro diagnostic use in the United States. In all countries where the use of this product has not been cleared by local regulating agencies, products using this technology shall not be used for diagnostic use as the performance characteristics have not been established. Two AtherOx products are CE-marked.
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 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
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