Corgenix Announces FDA Clearance for IgG Anti-AtherOx(R) Test Kit
10 April 2008 - 11:15AM
PR Newswire (US)
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:CONX)
(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. DATASOURCE: Corgenix Medical
Corporation CONTACT: William Critchfield, Senior VP and CFO of
Corgenix Medical Corp., +1-303-453-8903, fax, +1-303-453-8898, ; or
Dan Snyders, Vice President, Public Relations Supervisor, of Armada
Medical Marketing, +1-303-623-1190, ext. 230, fax, +1-303-623-1191,
Web site: http://www.corgenix.com/
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