Corgenix Announces FDA Clearance for IgG Anti-AtherOx(R) Test Kit

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

William Critchfield, Senior VP and CFO of Corgenix Medical Corp.,
+1-303-453-8903, fax, +1-303-453-8898, wcritchfield@corgenix.com; or Dan
Snyders, Vice President, Public Relations Supervisor, of Armada Medical
Marketing, +1-303-623-1190, ext. 230, fax, +1-303-623-1191,
dan@armadamedical.com