Navigation Links
Corgenix Announces FDA Clearance for IgG Anti-AtherOx(R) Test Kit
Date:4/10/2008

Next generation test for individuals with systemic lupus erythematosus and

lupus-like disorders expands Corgenix' extensive portfolio of

antiphospholipid products

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.

About AtherOx(R)

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.

Forward-Looking Statement

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.

References cited

Clinical & Developmental Immunology 2003; 10: 203-211.

American Journal of Pathology 2004; 121: 426-436.

Annals NY Academy of Sciences 2007; 1109: 303-310.


'/>"/>
SOURCE Corgenix Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Corgenix to Exhibit AspirinWorks(R) Test at ACC 2008 Meeting in Chicago
2. Corgenix Signs Technology Licensing Agreement With Japanese Government
3. Millennium Announces VELCADE(R) (Bortezomib) for Injection First-Quarter 2008 U.S. Net Sales
4. Oncothyreon announces effectiveness of shelf registration statement
5. Novagali Pharma Announces the Launch of Cationorm(R)
6. Lorus Therapeutics Announces Exclusive Multinational License Agreement with Zoticon Bioventures for Virulizin(R)
7. Dendreon Announces Closing of Registered Direct Offering
8. Diffusion Pharmaceuticals Announces Issuance of U.S. Patent No. 7351844, Titled Bipolar Trans Carotenoid Salts and Their Uses, for Its Family of First-In-Class Molecules
9. Caliper Life Sciences Announces Date and Location of its 2008 Annual Meeting of Stockholders
10. Cylex Announces Brad L. Stewart as President of the Company
11. Raven biotechnologies Announces Collaboration With Monogram Biosciences to Advance Diagnostic Cancer Technologies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... ... 20, 2017 , ... Parallel6™ , the leader in mClinical™ technologies for ... were named one of the 2017 Top 10 eClinical Trial Management Solution Providers ... industry. , “We take pride in honoring Parallel6 as one of the top 10 ...
(Date:4/20/2017)... For today, Stock-Callers.com redirects investors, attention ... and clinical research aimed at treating diseases and medical conditions. ... Biopharmaceuticals Inc. (NASDAQ: KERX), Kite Pharma Inc. (NASDAQ: KITE), and ... access our complimentary research reports on these stocks now at: ... http://stock-callers.com/registration ...
(Date:4/19/2017)... ... April 18, 2017 , ... Optofluidics today announced ... comes after the company changed focus to making analytical tools for biopharmaceutical quality ... new technology,” says CEO Robert Hart. Founders Bernardo Cordovez, Robert Hart and David ...
(Date:4/19/2017)... ... April 19, 2017 , ... As part of ... accessible to novices as well as experienced users, attendees will gain a better ... screening tests. , Hemostasis testing quality is determined by preanalytical variables which ...
Breaking Biology Technology:
(Date:3/20/2017)... -- PMD Healthcare announces the release of its new ... (WMS), a remote, real-time lung health monitoring and management ... a Medical Device, Digital Health, and Chronic Care Management ... solutions that empower people to improve their healthcare and ... the first ever personal spirometer, Spiro PD, which was ...
(Date:3/9/2017)... , Australia , March 9, ... study data at the prestigious World Lung Imaging Workshop ... Andreas Fouras , was invited to deliver the ... pulmonary medicine. This globally recognised event brings together leaders ... share the latest developments in lung imaging. ...
(Date:3/7/2017)... March 7, 2017   HireVue , the leading ... companies identify the best talent, faster, today announced the ... Officer (CSO) and Diana Kucer as Chief ... seasoned executive team poised to drive continued growth in ... a year of record bookings in 2017. ...
Breaking Biology News(10 mins):